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www.osactrial.org.uk
STANDARD OPERATING PROCEDURE FOR:
OSAC (Oral Steroids for Acute Cough) Trial
DRUG HANDLING
SOP Details:
Number: SOP-OSAC-0001 Version: 1.0
Author(s): Harriet Downing
Title: OSAC Trial Manager
Date: 27 Mar 2013
Authorised by: Dr Alastair Hay
Title: Chief Investigator
Date: 27 Mar 2013
Authorised by: Dr Birgit Whitman
Title: Sponsor
Date: 27 Mar 2013
Date operational: 1 May 2013
Date to be reviewed: 1 November 2013
Review History:
Review Date: Reviewed By:
Review amendments:
Amended date: Amended by:
Authorised date: Authorised by:
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Contents
1 Document History ......................................................................................................................................... 2
2 Background ................................................................................................................................................... 3
3 Purpose .......................................................................................................................................................... 3
4 Scope ............................................................................................................................................................. 3
5 Definitions & Abbreviations ......................................................................................................................... 3
6 Pre-Requisites ............................................................................................................................................... 3
6.1 Pre-Requisite Knowledge & Training ................................................................................................... 3
6.2 Pre-Requisite Equipment & Systems .................................................................................................... 3
7 Roles & Responsibilities ............................................................................................................................... 3
8 Procedure ...................................................................................................................................................... 4
8.1 Procedure Diagram................................................................................................................................ 4
8.2 Procedure Narrative .............................................................................................................................. 4
8.2.1 Receipt of OSAC Trial IMP by UH Bristol Pharmacy ........................................................................ 4
8.2.2 OSAC Trial IMP Storage at UH Bristol Pharmacy .............................................................................. 4
8.2.3 Randomisation ..................................................................................................................................... 5
8.2.4 Production of Patient Packs and delivery to UH Bristol Pharmacy ..................................................... 5
8.2.5 Allocation of IMP to Patient Packs by UH Bristol Pharmacy .............................................................. 6
8.2.6 Risk assessment of OSAC trial IMP storage locations at trial centres ................................................. 6
8.2.7 Risk Assessment Procedure ................................................................................................................. 6
8.2.8 Issue of OSAC Trial Patient Packs by UH Bristol Pharmacy to OSAC Trial Centres ......................... 7
8.2.9 Temperature Monitoring Procedure ..................................................................................................... 8
8.2.10 Significant Temperature Variations Reporting Procedure ............................................................ 8
8.2.11 Significant Temperature Variations Management Procedure ....................................................... 9
8.2.12 Issue of OSAC Trial Patient Packs to recruiting GP sites by OSAC Trial Centres ...................... 9
8.2.13 Issue of OSAC Trial Patient Packs to eligible, consented patients by recruiting GP sites ......... 10
8.2.14 Re-allocation of OSAC Trial Patient Packs from one recruiting GP site to another .................. 10
8.2.15 Return of any unused medication and empty medicine packs from patients to the Bristol trial
centre 10
8.2.16 Return of any unused Patient Packs from recruiting GP practices to the trial centres ................ 11
8.2.17 Management of any unused Patient Packs and medicine packs at the Bristol trial centre .......... 11
8.2.18 Shipment of any unused Patient Packs and medicine packs to UH Bristol for destruction ........ 11
9 Quality Control Measures ........................................................................................................................... 11
10 Related Documents ..................................................................................................................................... 12
11 Additional Guidelines ................................................................................................................................. 14
12 Appendices .................................................................................................................................................. 14
1 Document History
Revision Date Author Changes
1.0 27 Mar 2013 Harriet Downing None, this is the first draft
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2 Background
This document describes all of the procedures to be followed in the OSAC trial for the handling and
management of the IMP (Prednisolone or matched placebo).
3 Purpose
This is the reference document for the trial and should be used by all members of research and administrative
staff working on the trial.
4 Scope
The document refers to IMP management for the OSAC trial only.
5 Definitions & Abbreviations
IMP Investigational Medicinal Product
N/A Not Applicable
PID Patient Identification number
PP Patient Pack
PTF Pharmacy Trial File
RF Recruitment Folder
TMF Trial Master File
TSF Trial Site File
UHB University Hospitals Bristol NHS Foundation Trust
UoB University of Bristol
6 Pre-Requisites
None.
6.1 Pre-Requisite Knowledge & Training
Good Clinical Practice.
6.2 Pre-Requisite Equipment & Systems
None.
7 Roles & Responsibilities
Who What & Why
Chief Investigator Authorises this SOP.
Principal Investigator Ensures that this SOP is adhered to in all local sites. Delegates certain
activities to local researchers; all delegated activities documented on the
trial Delegation Log.
Piramal Healthcare / Mode Pharma Manufactures the IMP to quality standards, and delivers it to UH Bristol
Pharmacy in two equal batches in 2012/13 and in 2013/14. The second
batch is stored by Piramal until 2013/14.
Bristol Randomised Trials
Collaboration
Produces the randomisation schedule and sends this to UH Bristol
Pharmacy. Unblinds the trial data for review by the Data Monitoring
Committee.
UH Bristol Pharmacy Reviews this SOP and advises on content. Receives and stores the IMP
prior to dispatch to centres. Allocates the IMP to Patient Packs in line
with the Randomisation Schedule. Dispatches the IMP in blocks of four,
initially in batches of 44 Patient Packs to the trial centres.
Trial Sponsor (UoB) Reviews this SOP and approves content.
Trial Manager Updating of this SOP and adherence to content in all trial operations.
Trial Research Nurse Adherence to content of this SOP in all trial operations.
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Who What & Why
Trial Administrator Adherence to content of this SOP in all trial operations.
GP Practices Adherence to content of this SOP in all recruitment activity.
UH Bristol Monitor Monitors site adherence to this SOP within the monitoring plan.
8 Procedure
8.1 Procedure Diagram
See OSAC Trial Medicine Flow diagram (Appendix 1).
8.2 Procedure Narrative
Each of the stages through which the IMP will move during the progress of the trial are described below in
sequence.
8.2.1 Receipt of OSAC Trial IMP by UH Bristol Pharmacy
1. The trial medication will be shipped from Piramal Healthcare (Logistics Department, Piramal Healthcare,
Whalton Road, Morpeth, Northumberland, NE61 3YA, Tel: 01670 562 400) to UH Bristol Pharmacy
(Pharmacy Trials Unit, c/o Pharmacy Stores, Level 3 King Edward Building, Bristol Royal Infirmary,
Marlborough Street, Bristol, BS2 8HW, United Kingdom, Tel: 0117 342 3324).
2. The medicines will be transported in line with standard clinical shipping practice in the country of
manufacture of the 20mg prednisolone tablets (Germany). The manufacturer has confirmed that their
prednisolone is shipped under ambient conditions and that ICH stability data states that the 20mg
prednisolone tablets (Galen) can be stored at a temperature of up to 40°C and a relative humidity of 75% for
6 months, therefore short-term deviation from the normal storage temperature (15-25°C) is not critical and
thus short-term storage of up to 30°C is possible without any loss of quality.
3. The QP batch certificate will be sent to UH Bristol Pharmacy and stored in the pharmacy trial file. UH
Bristol Pharmacy will receive the delivery of IMPs. Prednisolone and placebo medicine packs to be in
separate, clearly labelled boxes. Each medicine pack shipped from Piramal to UH Bristol Pharmacy (which
will remain independent and unblinded throughout the trial) will be labelled with the MHRA-approved
labelling and carry a unique Medicine ID Number, which will also be printed onto three detachable stickers.
During the recruitment interview, these medicine ID number stickers will be removed from the medicine
pack (within the patient pack) by the Recruiting Clinician and affixed to (1) the completed Consent Form,
(2) the Trial Prescription which has been completed and authorised by the Responsible Clinician, and (3)
the Trial Participation Card.
4. Upon arrival at UH Bristol the contents of the delivery will be checked in line with UH Bristol’s Standard
Operating Procedure CT 2 01 (CT 2 01 Receipt and Recording of the safe delivery of Clinical Trial
Material).
5. The receipt of the medication and the completion of the UH Bristol checking procedure will be confirmed
to the trial centre by e-mail from UH Bristol Pharmacy to the OSAC Trial Manager.
6. UH Bristol Pharmacy will store the IMPs as per section 8.2.2.
8.2.2 OSAC Trial IMP Storage at UH Bristol Pharmacy
1. At UH Bristol, the trial medication will be stored below 25⁰C in the Pharmacy Trials Unit, pending the
allocation of medicine packs to the Patient Packs, and temperature monitoring will be carried out in line
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with the UH Bristol Safe Handling and Storage of Room Temperature Clinical Trial Material in Pharmacy
Trials Unit (CT 3 01).
8.2.3 Randomisation
1. A list detailing the contents of each medicine pack (active Prednisolone vs. Placebo), known as the
unblinded list, will be sent by Piramal Healthcare to UH Bristol following shipment of the IMP.
2. UH Bristol Pharmacy will record the medicine numbers of the medicine packs onto trial-specific Inventory
Logs for Active Medication and Placebo (Appendix 2).
3. An independent statistician from the Bristol Randomised Trials Collaboration will deliver to UH Bristol a
Randomisation Schedule of Participant ID numbers. This document, as well as the unblinded list and the
completed Inventory Logs, will be kept in the secure Pharmacy Trial File at UH Bristol.
4. No copies of any of the randomisation data will be kept at the trial centre (though a copy will be retained by
the Bristol Randomised Trials Collaboration). This is in order to ensure that the blinding of all of the trial
research team is maintained.
8.2.4 Production of Patient Packs and delivery to UH Bristol Pharmacy
5. Strips of 12 small yellow OSAC trial Patient ID labels will be prepared for each of the Patient ID numbers
generated by the Oxford clinical database programmer.
6. The following contents will be placed in the OSAC patient pack box by a member of the OSAC trial team:
a. Peak flow meter
b. £5 High Street Voucher in a thank you card
c. OSAC pen
d. Sheet of 12 Patient ID labels
e. OSAC trial canvas shopping bag
(The following patient pack items will be supplied to GP sites in the separate recruitment folder, and transferred
from the recruitment folder to the patient pack by the Recruiting Clinician during the recruitment interview:
f. Full Patient Information Booklet
g. Summary Patient Information Sheet
h. Consent form
i. Trial participation card)
j. Symptom diary
k. Laminated instruction sheet for using the peak flow meter
l. 1 padded freepost envelope (for the return of the trial medication packet)
m. 1 large freepost envelope (for the return of the symptom diary)
7. The contents of the box will be checked by a second member of the OSAC trial team, who will affix one of
the 12 Patient ID labels to the front of the Patient Pack, and return the remaining 11 to the box.
8. The assembled patient packs will be stored in sequential number order in the specified, risk-assessed
storage location. For each day of storage at the trial centre, the storage temperature will be monitored in line
with section 8.2.9.
9. The patient packs will be personally delivered to UH Bristol Pharmacy by a member of the trial team.
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8.2.5 Allocation of IMP to Patient Packs by UH Bristol Pharmacy
1. UH Bristol Pharmacy will receive the assembled Patient Packs from the Bristol trial centre.
2. UH Bristol Pharmacy will allocate the uniquely numbered medicine packs to the uniquely identified Patient
Packs according to the BRTC Randomisation Schedule for the corresponding centre, and in line with the
UH Bristol OSAC Trial Dispensing Procedure, inserting 1 medicine pack into each patient pack
accordingly.
3. For each Patient Pack, UH Bristol will affix one of the 12 small yellow Patient ID labels (included in the
Patient Pack) to the Medicine Pack, and write the appropriate number on the Drug Accountability Log.
4. UH Bristol Pharmacy will complete the UH Bristol OSAC Trial Pharmacy Drug Accountability Log
(Appendix 3). This is a record of matched Patient Pack ID Numbers to Medicine Pack Numbers, a copy of
which will be retained in the Pharmacy Trial File for unblinding purposes. No copy of this log will be held
at the trial centre, in order to maintain blinding for all research staff.
5. The fully assembled Patient Packs will be sealed and stored at UH Bristol Pharmacy Trials Unit, in
sequential number order and by centre, under the same conditions as the trial medicine packs (as the
medicine packs are now contained within the Patient Packs) pending distribution to the OSAC trial centres.
8.2.6 Risk assessment of OSAC trial IMP storage locations at trial centres
1. Prior to receiving any of the Patient Packs, each OSAC trial centre will be required to complete a risk
assessment, with reference to the proposed storage location. The aim of the risk assessment is to ensure that
clinical trial materials stored outside the UH Bristol Pharmacy are handled and stored in accordance with
applicable good manufacturing practice (GMP) and good clinical practice (GCP) regulations and as
specified by the sponsor. The OSAC trial protocol states that the “storage environment will be secure” (i.e.
a locked cabinet or room) “with access limited to members of the practice team recorded as being involved
in the trial. If sites have medication storage which is temperature monitored the trial medicines should be
stored there. Otherwise, the trial centre will ensure GP sites have minimum/maximum thermometers
available to monitor the temperature. The GP sites will check the temperature weekly and prior to issuing
medicines to recruited patients, recording the temperature on the temperature log and notifying the trial
centre if the temperature has exceeded 25°C.”
2. The IMP should be stored separately from other medication. If stored in the same area, the storage spaces
should be clearly distinguished.
3. Access to the locked storage area should be restricted to those persons with authority to handle the IMP as
stated on the OSAC Trial Centre Delegation Log.
4. Regular temperature monitoring of the storage facility must be undertaken (see section 8.2.9) and the local
OSAC trial centre team contacted if the temperature falls outside the specified range.
5. The OSAC trial IMP should be used only in accordance with the approved trial protocol.
8.2.7 Risk Assessment Procedure
1. The OSAC Trial IMP Storage Risk Assessment Form should be used to complete the risk assessment
(Appendix 4).
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2. The risk assessment should be carried out prior to the IMP arriving at the trial centre, and prior to the trial
opening at the recruiting GP practice.
3. The risk assessment should be completed by a member of the OSAC trial research team (for GP sites, this is
to minimise the burden on the practice team).
4. A named member of the OSAC trial research team (at the trial centre) or of the GP Practice team (at the
recruiting site) should take responsibility for the clinical trial material while it is stored outside pharmacy
and be responsible for temperature monitoring the clinical trial material and reporting temperature
deviations to the local trial centre (GP sites) and/or Bristol trial centre (trial centres). The name of this
person must be recorded in the OSAC Trial Delegation Log.
5. The local (centre or site) Principal Investigator must sign the completed form to acknowledge and confirm
that they are satisfied with the outcomes of the risk assessment.
6. The completed risk assessment forms should be filed in the centre/site trial file. A copy of any form
recording a ‘high’ or ‘medium’ risk, unacceptable storage location or actions to be taken should be faxed to
the Bristol trial centre who will arrange review, if appropriate, by an appropriately trained member of the
UH Bristol Pharmacy Clinical Trials Unit. Appropriate measures will then be taken in order to reduce the
level of risk to low.
7. The completed form must be filed in the centre or site OSAC trial file.
8. If any factors change during the trial, a new risk assessment must be carried out and a new assessment form
completed.
8.2.8 Issue of OSAC Trial Patient Packs by UH Bristol Pharmacy to OSAC Trial Centres
1. OSAC trial Patient Packs will be issued from UH Bristol directly to the four trial centres on completion of
Section1 the OSAC Trial Patient Pack Requisition and Transfer form (Appendix 5) by the Trial
Manager, who will send this to UH Bristol Pharmacy.
2. UH Bristol Pharmacy will confirm release of the patient packs in line with their standard internal processes.
Initially, 44 Patient Packs (in bundles of 4) will be sent to the requesting centre using the OSAC trial
courier, of which details are provided in Appendix 6 (towards the end of the trial, fewer patient packs may
need to be sent to centres depending on the progress of recruitment and the number of patient packs
remaining at UH Bristol Pharmacy). The courier pick-up will be arranged by the OSAC trial centre. The
Pharmacy will receive notification of the safe delivery of the patient packs to the trial centre, by the centres
faxing the signed transfer form to UH Bristol Pharmacy (0117 432 4304). The Pharmacy will store this
notification in the pharmacy trial file.
3. Trial patient packs will be issued to recruiting trial centres in sequential order of Patient Pack ID number, as
the medicine has been randomised to the patient packs prior to receipt of completed patient packs by the
trial centres. The Pharmacy will summarise the specific patient pack numbers to be issued in Section 2 of
the Requisition, Transfer and Receipt form. A hard copy of all the form will be sent with the Patient Pack
Shipment to the trial centre. For patient pack deliveries to the Oxford, Southampton and Nottingham
centres, a copy of the Requisition, Transfer and Receipt form will also be sent to the Bristol trial centre.
4. Upon receipt of the Patient Packs at the trial centre, a member of the Research team will check the contents
of the Shipment, complete Section 4 and fax a copy to the Bristol trial centre.
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5. The Trial Manager will double-check that all sections of the form are consistent and complete, in order to
confirm that the specific patient packs issued match those that have been received at the trial centres, and
enter the Patient Pack transfer data onto the Trial management database.
6. The Patient Packs will be transferred to the designated, risk assessed storage area (see section 8.2.6).
7. The temperature of the storage area will be monitored on a weekly basis as per the procedure outlined in
8.2.9.
8.2.9 Temperature Monitoring Procedure
1. The designated member of staff will monitor the storage temperature of the trial medication weekly and
record the findings on the OSAC Trial Temperature Monitoring Log (Appendix 7).
2. Temperatures should be read on the first working day of every week (preferably first thing in the morning).
3. Record the minimum and maximum temperature from the calibrated digital thermometer (see Appendix 8
for details of the model to be used) in the IMP storage area.
4. Reset the thermometer by pressing the reset button.
5. Complete all sections of the temperature monitoring log.
6. File completed temperature logs in the OSAC trial file.
7. If for any week the minimum or maximum temperature falls outside the accepted range (15⁰C to 25⁰C),
OSAC trial centres should fax a copy of the log to the Bristol trial centre. (GP Practices should fax their log,
in the case of temperature deviations, to their local trial centre).
8. The Bristol trial team will enter all site temperature monitoring data onto the Trial Management Database.
8.2.10 Significant Temperature Variations Reporting Procedure
1. The Bristol Centre will keep a cumulative log of the number of weeks on which significant temperature
variations have occurred for any trial centre. OSAC trial centres will keep a cumulative log of the number
of weeks on which significant temperature variations have been reported for any participating GP site.
These variations will be recorded on the OSAC Trial Significant Temperature Variations Log
(Appendix 10).
2. Should a temperature variation be recorded for any single site on more the 15 weeks, this will be taken by
the trial team to represent, cumulatively, a significant percentage of the 6 month period covered by the
Galen stability data (Appendix 9).
3. If this happens for any participating GP practice, the Significant Temperature Variations Log will be faxed
by the local trial centre to UH Bristol Pharmacy, with a copy to the Bristol trial centre. UH Bristol
Pharmacy will then follow the Significant Temperature Variations Management Procedure (see section
8.2.11).
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8.2.11 Significant Temperature Variations Management Procedure
1. The OSAC trial centre or GP site about which the significant temperature variations report has been made
will be asked by the Bristol trial centre (OSAC trial centres) or by the local trial centre (GP Practices) to
clearly mark all OSAC patient packs with “IN QUARANTINE. DO NOT USE” and inform all members of
staff involved in the trial (trial centres) or in recruiting patients and issuing the Patient Packs (GP Practices).
2. UH Bristol Pharmacy will decide, on the basis of all available information, whether or not the OSAC trial
IMPs are fit or unfit for use. The Pharmacy may need to contact Piramal for advice.
3. If the clinical trial material is deemed unfit for use, the affected stock should remain in quarantine and
replacement stock should be ordered. OSAC trial centres should contact the Bristol Centre to arrange
transfer of the quarantined stock back to UH Bristol Pharmacy for destruction.
4. Quarantined stock must be stored separately from “active” stock.
5. If the clinical trial material is deemed fit for use, remove the stock from quarantine. Inform all members of
staff involved in the trial (trial centres) or in recruiting patients and issuing the Patient Packs (GP Practices).
6. Ensure you have written confirmation from UH Bristol pharmacy confirming whether the stock is fit or
unfit for use. File this in the OSAC centre / site trial file.
8.2.12 Issue of OSAC Trial Patient Packs to recruiting GP sites by OSAC Trial Centres
1. A member of the OSAC trial research team responsible for setting up the GP site should carry out the
OSAC Trial IMP Storage Risk Assessment, for the proposed storage location, on behalf of the GP Practice
(see section 8.2.7), prior to the delivery of Patient Packs to the site.
2. GP Practices will be provided with OSAC trial calibrated digitial minimum / maximum thermometers (see
Appendix 8 for details) either before or at the same time as the first delivery of Patient Packs to the site.
3. At the start of recruitment each participating GP practice will be provided with 4 Patient Packs and
associated Recruitment Folders. Prior to shipment, the local trial centre will complete Section 2 of the
Requisition, Transfer and Receipt Log.
4. A printed copy of the Requisition, Transfer and Receipt Log will be included with the delivery of Patient
Packs.
5. The local trial centre will record the details of which patient packs have been sent to which GP site in the
OSAC Trial Centre Patient Pack Accountability Log (Appendix 11), and check this prior to any Patient
Packs leaving the trial centre.
6. A nominated member of staff at the recruiting GP Practice will check the ID numbers of the Patient Packs
they receive, and acknowledge and sign for these in Section 4 of the Requisition, Transfer and Receipt
Form, a copy of which will be faxed back to the local trial centre.
7. The designated member of staff at the GP practice will also complete the OSAC Trial GP Practice Patient
Pack Accountability Log (Appendix 12).
8. The designated member of staff will follow the weekly IMP Storage Temperature Monitoring Procedure
(see section8.2.9).
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9. Staff at the local trial centre will check that the Patient Pack numbers on the Requisition, Transfer and
Receipt Form match those that have been received, and record this in the Trial Site File.
10. If the recruiting GP Practice needs more packs, they will complete the Requisition section of the
Requisition, Transfer and Receipt Form and send this to their local trial centre. The local trial centre will
then issue the GP Practice with a further 4 packs, which will be recorded on issue and on receipt as
described above.
11. The local trial team will receive copies of all centre Requisition, Transfer and Receipt forms by secure fax
after each transfer, and enter the data onto the Trial Management Database.
8.2.13 Issue of OSAC Trial Patient Packs to eligible, consented patients by recruiting GP sites
1. Patient packs will be allocated to patients for whom a GCP-trained GP has authorised the OSAC trial
prescription, and from whom written consent has been obtained by a GCP-trained clinician, in sequential
number order.
2. GP practices will record the allocation of patient packs to patients by updating the OSAC Trial GP
Practice Patient Pack Accountability Log (Appendix 12).
3. The Bristol centre will use this data to update the OSAC Trial Master Patient Pack Accountability Log
(Appendix 13) and will enter these data electronically into the Trial Management Database.
8.2.14 Re-allocation of OSAC Trial Patient Packs from one recruiting GP site to another
1. OSAC Trial Patient Packs must not be re-allocated or transferred to another site. In exceptional
circumstances a decision may be taken by the Trial Management Group, with the agreement of the Sponsor,
to arrange for re-allocation in a manner which maintains the integrity of the randomisation.
8.2.15 Return of any unused medication and empty medicine packs from patients to the Bristol trial
centre
1. Patients are asked to return unused trial medication, and/or the empty medicine packs from the Patient Pack,
to the trial centre by post using the OSAC Trial prepaid addressed return medicine packaging. The patient
will be advised of this requirement in the following ways:
1) During the training for follow-up provided by the recruiting clinician as they administer the patient
pack to the patient. The return envelope will be contained in the Recruitment Folder, and passed by the
recruiting clinician to the patient during the recruitment process. The physical handover of the
medicine return packaging from the recruitment folder to the patient – who will be asked to store it
within their patient pack – will help to emphasise the importance of this part of the patient training
process and lessen the possibility of this being overlooked or forgotten by the clinician or the patient.
2) The requirement is specified as an action after Day 5 within the Patient Symptom and Recovery Diary.
3) The patient will be reminded of this requirement by the Research Nurse during the Day 7 follow-up
telephone call, and asked to return the medicine packet (and any unused medication) if they have not
already done so.
2. GP Practices will be provided with a few spare pre-paid envelopes (the same as those provided to the
patients for returning the medication) in case any patients give any unused trial medication back to the GP
practice. This could then be returned directly by the GP practice to the Bristol trial centre.
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3. The Bristol trial centre will count and record all returned medicine packets and unused medicines in the
Master Patient Pack Accountability Log and electronically in the Trial Management Database.
4. The empty medicine packets and unused medicines will be stored, separately from the unused trial
medication to be dispensed for recruitment, until the end of the recruitment period.
5. When each sheet of the Master Patient Pack Accountability Log is complete, the Bristol trial team will
arrange for this to be signed off by the Chief Investigator and by the UH Bristol Pharmacy, to confirm that
all trial medication is accounted for.
8.2.16 Return of any unused Patient Packs from recruiting GP practices to the trial centres
1. GP sites will be required to return any unused Patient Packs to the local trial centre at the end of their
involvement in recruitment.
2. The Patient Packs to be returned will be recorded by the GP sites on the Requisition, Transfer and Receipt
form and sent to the local trial centre, who will record receipt of the transferred material on their Receipt
section of the form and check this against the Centre Patient Pack Accountability Log to ensure that all
Patient Packs provided to the recruiting site have been accounted for (either as issued to a patient, or as
returned to the local centre.
3. Unused patient packs will be stored at the local trial centres until a decision is made by the TMG as to
whether the IMPs will need to be reallocated (in this case all unused patient packs will be returned to UH
Bristol Pharmacy].
8.2.17 Management of any unused medicines and empty medicine packs at the Bristol trial centre
1. Once recruitment is complete, all empty medicine packs will be destroyed. Either all empty packaging will
be placed into University of Bristol confidential waste disposal system, or the label containing the Patient
Identification Number will be removed and placed in confidential waste, and the remainder disposed of as
domestic waste. The Master Patient Pack Accountability Log will be updated to record that the packaging
has been destroyed.
2. All unused medications will be delivered by the Bristol trial centre to UH Bristol Pharmacy. The
medications will be accompanied by a copy of the Master Patient Pack Accountability Log which will
account for all of the Patient Packs which have been issued from UH Bristol Pharmacy (via the trial centres
and GP practices) during the trial. As the Master Patient Pack Accountability Log contains patient
information, this must be transferred to the Pharmacy by secure courier or by hand delivery by a member of
the OSAC trial research team.
8.2.18 Destruction of unused medication
1. The Pharmacy will update the UH Bristol OSAC Trial Pharmacy Drug Accountability Log to account
for all trial tablets, and arrange for the medicine to be destroyed line with their standard procedure (CT 4 01
Return and Disposal of Unused Clinical Trial Material).
9 Quality Control Measures
All centres will go through the trial sponsor Green light Process before the trial is initiated at any recruiting site.
The OSAC trial monitoring plan will include checking that the above processes are being followed.
Page 12
OSAC Trial SOP Drug Handling v1.0 (27 Mar 2013) FINAL VERSION Printed: Wed, 1 May 2013 UNCONTROLLED WHEN PRINTED Page 12 of 28
www.osactrial.org.uk
10 Related Documents
Document name Document owned
by
Version no. /
date
Appended to this
document
For use by Filing / Storage
Summary of medicinal product characteristics (120903
Prednisolone Galen 20mg SmPC English FINAL (03
September 2012)
Piramal 3 September
2012
No Investigators TMF
Piramal Healthcare Certificate of Confirmity (Certificate
of Confirmance OSAC trial IMPs CofC B03404 (sent by
Gillian Nicholson 20 Dec 2012)
Piramal N/A No Piramal TMF
Piramal Healthcare Distribution Instructions and Order
Acknowledgement Form (SOP-000570)
Piramal 15.0 No Piramal TMF
OSAC Trial Centre Piramal Drug Request Form v1.0 (21
December 2012)
OSAC Trial
Centre (adapted
from Piramal
template)
1.0 (21
December 2012)
No OSAC trial centre
(Bristol)
TMF
UH Bristol Standard Operating Procedure CT 2 01
Receipt and Recording of the safe delivery of Clinical
Trial Material
UH Bristol 2.0 (17 August
2010)
No UH Bristol Pharmacy PTF
UH Bristol Standard Operating Procedure for Safe
Handling and Storage of Room Temperature Clinical
Trial Material in Pharmacy Trials Unit (CT 3 01)
UH Bristol 3.0 (05 Nov
2012)
No UH Bristol Pharmacy PTF
Piramal OSAC Trial Unblinded List Piramal N/A No UH Bristol Pharmacy PTF
UH Bristol OSAC Trial Inventory Logs, blank (ACTIVE
and PLACEBO)
UH Bristol N/A Appendix 2 UH Bristol Pharmacy PTF
OSAC Trial Randomisation Schedule BRTC N/A No UH Bristol Pharmacy PTF, BRTC
UH Bristol OSAC Trial Dispensing Procedure UH Bristol 1 (22/03/2013) No UH Bristol Pharmacy PTF
UH Bristol OSAC Trial Pharmacy Drug Accountability
Log
UH Bristol N/A Appendix 3 UH Bristol Pharmacy PTF
UH Bristol SOP CT 1 04 Risk assessment for storing
clinical trial material outside of pharmacy version 2 (used
as reference source for sections 8.2.6-7 and for the risk
assessment form in Appendix 4)
UH Bristol 2.0 (5 Nov
2012)
No UH Bristol Pharmacy TMF
OSAC Trial GP Practice Delegation Log OSAC Trial
Centre
1.0 No OSAC trial centres
(all centres)
TMF
Page 13
SOP-OSAC-0001 CONFIDENTIAL: UNAUTHORISED COPYING PROHIBITED
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Document name Document owned
by
Version no. /
date
Appended to this
document
For use by Filing / Storage
OSAC Trial Centre Delegation Log OSAC Trial
Centre
1.0 No OSAC trial centres
(all centres)
TMF
UH Bristol CT 4 01 Return and Disposal of Unused
Clinical Trial Material version 3
UH Bristol 3.0 (8 Nov
2012)
No Pharmacy PTF
Page 14
OSAC Trial SOP Drug Handling v1.0 (27 Mar 2013) FINAL VERSION Printed: Wed, 1 May 2013 UNCONTROLLED WHEN PRINTED Page 14 of 28
www.osactrial.org.uk
11 Additional Guidelines
None other than those referred to in section 10 (Related Documents).
12 Appendices
Appendix 1 OSAC Trial Medicine Flow Diagram
Appendix 2 UH Bristol OSAC Trial Inventory Logs (active and placebo)
Appendix 3 UH Bristol OSAC Trial Accountability Log for Patient Packs
Appendix 4 OSAC Trial IMP Storage Risk Assessment Form
Appendix 5 OSAC Trial Patient Pack Requisition, Transfer and Receipt Form
Appendix 6 Details of courier service used for OSAC patient pack distribution
Appendix 7 OSAC Trial IMP Storage Temperature Monitoring Log
Appendix 8 Details of thermometer used to monitor IMP storage temperature
Appendix 9 Stability data communicated by GALENpharma GmbH regarding the Prednisolone to be used
in the OSAC trial
Appendix 10 OSAC Trial Significant Temperature Variations Log
Appendix 11 OSAC Trial Centre Patient Pack Accountability Log
Appendix 12 OSAC Trial GP Practice Patient Pack Accountability Log
Appendix 13 OSAC Trial Master Patient Pack Accountability Log
Page 15
OSAC Trial SOP: IMP Handling Appendix 1: Trial Medicine Flow Diagram
OSAC Trial SOP Drug Handling v1.0 (27 Mar 2013) FINAL VERSION Printed: Wed, 1 May 2013 UNCONTROLLED WHEN PRINTED Page 15 of 28
Dev elop placebo Acquire prednisolone f rom within the EU MANUF AC TURING
COMPAN Y
Package as per IMP spec
Send IMP test samples to SSCM
3 months prior to deliv ery
Send code break scratch
cards to UH Bristol
Deliv er half of total tender to UHB (equal
packs of Prednisolone and placebo)
Test IMP (activ e and placebo) f or similarity and quality
Second half of tender stored at
manuf acturing company
As needed, put relev ant medicine pack in patient packs as per randomisation schedule
UH Bristol complete label
section with patient number
UH Bristol keep record of matching patient pack and
medicine pack numbers to store with code break card
UH Bristol sign off and log which patient packs are sent
BRTC send randomisation
schedule to UH Bristol UH BRISTOL
Order sent through to
UH Bristol via SSCM
BRTC
Send 44 packs (in bundles of 4) to
SSCM f or f irst recruiting season
Send 44 packs (in bundles of 4) to each of the
study centres f or second recruiting season
Send 4 patient packs
to GP practice
TRI AL
CENTRES
Centre to log which patient packs
are sent to which GP practice
Storage of packs at recruiting centres
Deliv ery organised through
centre co-ordinator
Storage of packs at UH Bristol
Centre has suffi-
cient packs? YES
NO
GP practice sign f or and acknowledge receipt of patient
packs (e-mail patient pack numbers to recruiting centre)
Patient packs (including IMPs) av ailable
at GP practice f or clinicians to dispense
RECRUITING GP
PR ACTICES
GP practice has only
1 patient pack left
Practice sends through
order f orm to trial centre
Patient packs to be stored in secure
env ironment with access limited to trial
staff as per delegation log
Weekly temperature check and log
Report any weekly temperature
dev iations to the local trial centre
Responsible Clinician checks patient is eligible by
completing CRF 1 and 2
GP arranges f or patient to see Recruiting Clinician
Responsible Clinician authorises trial prescription
Recruiting clinician will: (1) Consent patient; (2) Give them their trial participation card (after hav -
ing attached the PID and med ID stickers); (3) explain all contents of the patient pack including the trial
medication; (4) ensure that all documents are correctly labelled with the PID and medicine ID stickers
as per recruitment protocol; (5) enter data onto the secure online database
Ask patients to return any unused IMP to Bristol
centre in prepaid return env elope prov ided
Any unused IMP returned by patient to SSCM f or counting
At the end of recruitment, all unused packs to be returned, v ia trial
centres, to SSCM f or counting, and to UH Bristol f or destruction
Emergency unblinding to be
done v ia contact with UH Bristol
UH Bristol to record reason f or
unblinding in online sy stem
If any cause to require unblinding, GP or pa-
tient to call number on trial participation card
UH
BRISTOL
Page 16
OSAC Trial SOP: IMP Handling Appendix 2: Inventory Logs for Active and Placebo Medication
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Page 17
OSAC Trial SOP: IMP Handling Appendix 3: UH Bristol Pharmacy Drug Accountability Log
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Page 18
OSAC Trial SOP: IMP Handling Appendix 4: OSAC Trial IMP Storage Risk Assessment Form
OSAC Trial SOP Drug Handling v1.0 (27 Mar 2013) FINAL VERSION Printed: Wed, 1 May 2013 UNCONTROLLED WHEN PRINTED Page 18 of 28
1. A member of the OSAC trial research team should complete this form for each storage location (trial centre or recruiting GP
practice) of the fully assembled (i.e. containing the IMP) patient packs in line with the procedure described in section 8.2.6.
Please complete all unshaded parts of the form.
2. NB: OSAC trial IMP cannot be stored outside of the UH Bristol Pharmacy unless a risk assessment has been conducted, the
sponsor is in agreement and the investigator has authorised the risk assessment form.
3. File the completed form in the centre/site trial file and fax a copy to the Bristol trial centre on 0117 938 7341.
Title of study protocol OSAC (Oral Steroids for Acute Cough)
Protocol Name / Number 12/SW/0180
EudraCT Number 2012-000851-15
Sponsor University of Bristol (sponsor ref: 1581)
Chief Investigator Dr Alastair Hay, University of Bristol
Reason for assessment Proposed storage of OSAC trial patient packs containing the trial IMPs in line with the
trial protocol.
Local trial centre
Bristol Oxford Nottingham Southampton
(Please place a cross in the appropriate box)
Storage at trial centre or at GP
practice?
Trial centre GP Practice
If GP Practice, name of site
Proposed location for the clinical trial material
Security (limited access, designated lockable
fridge/cupboard)
Description of trial material Patient packs [insert dimensions] containing patient materials including medicine packs
which contain the trial IMP (10 x Prednisolone 20mg or Placebo-to-match tablets)
Storage requirements for the clinical trial material (fridge,
freezer, ambient) Ambient
Acceptable storage temperature range
(2 - 8°C, -20 +/- 5°C, 15 – 25°C, 15 – 30°C) 15 – 25°C
Details of the temperature monitoring device (e.g.
calibrated min/max thermometer)
OSAC trial calibrated min/max thermometer. Weekly temperature
monitoring. Fax log to trial centre if temperature falls out of range
within any one week.
Person(s) responsible for temperature monitoring and
reporting deviations As per centre / site OSAC Trial Delegation Log
Date risk assessment conducted
_ _ / _ _ / _ _ _ _ (dd / mm / yyyy)
Assessment conducted by:
(sign /print name)
Outcome of risk assessment
High Medium Low
Storage location acceptable
YES NO
Actions/Comments:
Authorised by (Principal Investigator at
trial centre or recruiting GP practice)
(sign /print name)
Date risk assessment authorised
_ _ / _ _ / _ _ _ _ (dd / mm / yyyy)
Page 19
OSAC Trial SOP: IMP Handling Appendix 5: OSAC Trial Patient Pack Requisition, Transfer and Receipt Form
OSAC Trial SOP Drug Handling v1.0 (27 Mar 2013) FINAL VERSION Printed: Wed, 1 May 2013 UNCONTROLLED WHEN PRINTED Page 19 of 28
PAGE 1 OF 2
SECTION 1: Requesting OSAC Trial Centre / GP Practice to complete to order Patient Packs:
OSAC Trial Centre / GP Site
Name:________________________________________________________________________
Request supply of:
Quantity Investigational Medicinal Product
___________ (multiple of 4)
OSAC Trial Patient Packs containing Prednisolone 20mg or Placebo tablets X 10
Requested by (signature): ____________________ Print name:________________________________________________
Date: ___ / ___ / _____ (dd / mm / yyyy) Telephone Number: _________________________________________
Requesting GP practices: please fax Page 1 of this form to your local trial centre. File the original in your site trial file.
Requesting OSAC trial centres: please fax Page 1 of this form to the Bristol trial centre. File the original in your centre
trial file.
Bristol trial centre: please fax this form to UH Bristol Pharmacy. File the original in the TMF.
SECTION 2: UH Bristol Pharmacy / Issuing OSAC Trial Centre to complete on issue of Patient
Packs to the requesting trial centre / site:
OSAC Trial Centre (name) or UH Bristol
Pharmacy:___________________________________________________________
Number of OSAC Trial Patient Packs issued: ______________________ (multiple of 4)
Patient Identification Numbers of the packs issued: ___________________ to ___________________ (must be
consecutive)
Dispensed by: _____________________________________________________ Date: ___ / ___ / _____ (dd / mm /
yyyy)
Checked by: _______________________________________________________ Date: ___ / ___ / _____ (dd / mm /
yyyy)
Transfer from (name storage location): ____________________________________________________________________
While the investigational medicinal product has been held at the above storage location I can confirm that it has been stored
according to the recommended conditions and the packaging is intact prior to transfer.
Released by (signature): ____________________ Print name:_________________________________________________
On date: ___ / ___ / _____ (dd / mm / yyyy) At time: ____ : ____ (24 hour clock)
UH Bristol Pharmacy: Take a copy of this form and send with the Shipment. File original in pharmacy file.
Issuing OSAC trial centres: Take a copy of this form and send with the Shipment. File original in the trial file.
UH Bristol and issuing centre: When the courier company arrives to collect the Shipment, ensure that the courier
completes section 3 of this form (on Page 2).
Page 20
OSAC Trial SOP: IMP Handling Appendix 5: OSAC Trial Patient Pack Requisition, Transfer and Receipt Form
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PAGE 2 OF 2
SECTION 3: Courier Company to complete on collection of Patient Packs:
Transferred by (Courier Company):_______________________________________________________________________
Accepted by (signature): _____________________________ Print name:________________________________________
On date: ___ / ___ / _____ (dd / mm / yyyy) At time: ____ : ____ (24 hour clock)
SECTION 4: Receiving OSAC Trial Centre / GP practice to complete on receipt of Patient Packs:
Transferred to OSAC Trial Centre (name) / GP Site (name of site):
_______________________________________________
Received by (signature): ___________________________ Print
name:___________________________________________
On date: ___ / ___ / _____ (dd / mm / yyyy) At time: ____ : ____ (24 hour clock)
State of Study Medication: Acceptable / Not Acceptable (please circle)
Please provide details: _________________________________________________________________________________
____________________________________________________________________________________________________
Signature: _________________________________________
Receiving GP practices: Take a copy of this form and fax to your local trial centre. File original in site file.
Receiving OSAC trial centres: Take a copy of this form and fax to the Bristol trial centre. File original in the centre trial
file.
Receiving GP practices and OSAC trial centres: Place OSAC Treatment Packs in the designated and risk-assessed
storage location.
Page 21
OSAC Trial SOP: IMP Handling Appendix 6: OSAC Trial Courier (used to transport Patient Packs)
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Details to be added.
Page 22
OSAC Trial SOP: IMP Handling Appendix 7: OSAC Trial IMP Storage Temperature Monitoring Log
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The designated member of the OSAC research team (trial centres) or GP practice team (recruiting sites), as recorded on
the OSAC Trial Delegation Log, should complete this temperature log at the beginning of each working week during
which the site is involved in the OSAC trial.
Date on which
Patient Packs
received:
____ / ____ / _______ (dd/mm/yyyy) Patient Packs to be stored at room temperature,
below 25°C
Name of trial centre
or recruiting GP
practice:
Risk assessment
completed and
authorised? (yes/no)
Date
(dd/mmm/yy)
Time
(24hr format)
Minimum
Temperature (°C)
Accepted minimum =
15°C
Maximum
Temperature (°C)
Accepted maximum
= 25°C
Pass / Fail Initials
: °C °C
: °C °C
: °C °C
: °C °C
: °C °C
: °C °C
: °C °C
: °C °C
: °C °C
: °C °C
: °C °C
: °C °C
: °C °C
: °C °C
: °C °C
: °C °C
: °C °C
GP Practices: Please report any temperature deviations (“Fail”) by faxing this form to your local trial centre.
OSAC trial centres: Please report any temperature deviations (“Fail”) by faxing this form to the Bristol trial centre.
Page 23
OSAC Trial SOP: IMP Handling Appendix 8: Details of the thermometer used for monitoring IMP storage temperature in the OSAC trial
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Page 24
OSAC Trial SOP: IMP Handling Appendix 9: Stability data communicated by GALENpharma GmbH regarding Prednisolone used in the OSAC trial
OSAC Trial SOP Drug Handling v1.0 (27 Mar 2013) FINAL VERSION Printed: Wed, 1 May 2013 UNCONTROLLED WHEN PRINTED Page 24 of 28
From: "Oliver Gupta" <[email protected] >
To: "'Harriet Downing'" <[email protected] >
Cc: "Rima Gupta" <[email protected] >,
<[email protected] >,
"'JASON KNIGHT'" <[email protected] >
Subject: RE: OSAC trial - storage of Prednisolone above 25deg C
Date: Tue, 28 Aug 2012 11:25:43 +0100
Dear Harriet,
I am forwarding an email response from GalenPharma (the marketing authorisation holder of the Prednisolone 20mg) below. It is in German but
the translation is as follows:
"According to the current ICH stability data for our prednisolone 20 mg GALEN, tablets storage at a temperature of 40°C and a relative
humidity of 75% for 6 months is possible. It follows that a short-term deviation from the normal storage temperature (25°C) is not critical, ie
short-term storage of up to 30°C is possible without any loss of quality. The above mentioned ICH stability data will be presented to the
licensing authority in the foreseeable future, and with this the existing storage conditions will be removed."
I hope this clarifies any doubts about the temporary storage of the active product at temperatures above 25degC.
Best wishes,
Oliver
MODEPHARMA - Medication and Services for Clinical Trials
Phone: +44 207 0432 442
Mobile: +44 774 070 1015
www.modepharma.com
-----Original Message-----
From: Neujahr (GALENpharma) [mailto:[email protected] ]
Sent: 28 August 2012 11:19
To: '[email protected] '
Subject: AW: Prednisolon 20 mg GALEN, Tabletten
Sehr geehrter Herr Gupta,
gemäß den aktuellen ICH-Stabilitätsdaten für unsere Prednisolon 20 mg GALEN, Tabletten ist die Lagerung bei einer Temperatur von 40°C und
einer relative Luftfeuchtigkeit von 75% über 6 Monate möglich. Daraus ergibt sich, dass eine kurzfristige Abweichung von der üblichen
Lagertemperatur (bis 25°C) unkritisch ist, d.h. eine kurzfristige Lagerung bis zu 30°C ohne Qualitätseinbußen möglich ist. Die o.g. ICH-
Stabilitätsdaten werden wir der Zulassungsbehörde in absehbarer
Zeit anzeigen; damit entfällt der bisherige Lagerhinweis.
Freundliche Grüße
Hans Neujahr
_________________________
Dr. Hans Neujahr
Med.-Wiss., IB § 74a AMG
GALENpharma GmbH
Wittland 13
D- 24109 Kiel
Tel.: +49 (0) 431/58 518 16
Fax: +49 (0) 431/58 518 516
e-Mail: [email protected]
Geschäftsführer: Jan Paul Paulsen
Handelsregister: Nr. 5 HRB 2237
Amtsgericht Kiel
Page 25
OSAC Trial SOP: IMP Handling Appendix 10: Significant Temperature Variations Log
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The designated member of the OSAC research team (Oxford, Nottingham, Southampton and Bristol trial centres), as recorded on the OSAC Trial Delegation Log, should complete this log
whenever a significant temperature variation is reported (by means of faxing the IMP Storage Temperature Monitoring Log). When the number of weeks for which a significant temperature
variation is reported for any single site, this log should be faxed to UH Bristol Pharmacy who will then follow the Significant Temperature Variations Management Procedure.
Date of
temperature
variation report
(dd/mm/yyyy)
Name of site (name of
OSAC trial centre or GP
practice)
Type of variation:
Positive = > 25 ⁰C;
Negative = < 15 ⁰C
Maximum
temperature
reported (⁰C)
Cumulative number of weeks
for which significant
temperature variation reported
for this site (up to 15 weeks)
Reported to UH
Bristol Pharmacy
(at 15 weeks)
Name of person making
report to UH Bristol
Pharmacy
The local centre PI
should sign here to
confirm that
appropriate action has
been taken
Page 26
OSAC Trial SOP: IMP Handling Appendix 11: OSAC Trial Centre Patient Pack Accountability Log
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FOR COMPLETION BY OSAC TRIAL CENTRES
Trial: OSAC (Oral Steroids for Acute Cough) Sponsor: University of Bristol
Chief Investigator: Dr Alastair Hay EudraCT Number: 2012-000851-15
IMP: Prednisolone 20mg or Placebo tablets x 10
Name of OSAC trial centre:
RECEIVED AT TRIAL CENTRE ISSUED TO GP PRACTICES
Date
(dd/mm/yyyy)
Participant ID
number
Received by
(initials)
Date
(dd/mm/yyyy)
Name of GP Practice Issued by
(initials)
Please keep a copy of this accountability log in your centre trial file.
Page 27
OSAC Trial SOP: IMP Handling Appendix 12: OSAC Trial GP Practice Patient Pack Accountability Log
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FOR COMPLETION BY PARTICIPATING GP PRACTICES
CONFIDENTIAL: PATIENT INFORMATION Do not store or transmit other than by approved data protection methods. Please contact your local trial centre
with any queries.
Trial: OSAC (Oral Steroids for Acute Cough) Sponsor: University of Bristol
Chief Investigator: Dr Alastair Hay EudraCT Number: 2012-000851-15
IMP: Prednisolone 20mg or Placebo tablets x 10
Name of GP Practice:
RECEIVED BY GP PRACTICE ISSUED TO PATIENTS
Date
(dd/mm/yyyy)
Participant
ID number
Received by
(initials)
Date of issue
(dd/mm/yyyy)
Medicine ID
number
Patient
initials
Patient date
of birth
(dd/mm/yyyy)
Issued by
(initials)
Please keep a copy of this accountability log in your site file.
Page 28
OSAC Trial SOP: IMP Handling Appendix 13: OSAC Trial Master Patient Pack Accountability Log
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TO BE COMPLETED BY BRISTOL TRIAL CENTRE FOR ALL OSAC PATIENT PACKS ISSUED BY UH BRISTOL PHARMACY
CONFIDENTIAL: PATIENT INFORMATION Do not store or transmit other than by approved data protection methods.
Participant
ID
Medicine
ID
Issued to
patient on
date
(dd/mm/yyyy)
Patient
D.O.B.
(dd/mm/yyyy)
Patient
initials
Name of issuing GP
Practice
Medicine
pack
returned to
Bristol
centre?
(tick)
Date on
which
medicine
pack
returned to
Bristol centre
(dd/mm/yyyy)
Contents
of
medicine
pack
(number of
tablets)
Initials of
person
counting
the tablets
Date on which
any unused
medications
transferred to UH
Bristol for
destruction
(dd/mm/yyyy)
Date on which
destruction
confirmed by
UH Bristol
(dd/mm/yyyy)
When complete, this form should be signed off by the Chief Investigator and a member of staff at UH Bristol Pharmacy.
I confirm that all IMPs issued for the OSAC trial as listed in the above patient packs have been accounted for:
Signature of Chief
Investigator:
Print name: Date
(dd/mm/yyyy)
Signature of representative
of UH Bristol Pharmacy:
Print name: Date
(dd/mm/yyyy)