WP 9-10 GRACE Online System GRACE Online System WP9-10 Frank Leus 14 September 2007 Stockholm.

WP 9-10 GRACE Online System

GRACE Online System

WP9-10

Frank Leus

14 September 2007 Stockholm


• Visit codes

• Labels

• GRACE packs

• Study flows

• Survey tasks and human tasks

WP 9-10 GRACE Visit Codes

Visit codes

Patients

V1 = Visit 1 Inclusion of patient

V2 = Visit 2 4 weeks after inclusion of patient

Controls

V0 = Inclusion of control

WP 9-10 GRACE Yellow labels for forms

Yellow labels for patients

15 labels per patient for V1 and V2

Labels provided for 350 patients per Network

Labels consist of Patient Study Number followed by ‘Pt’ e.g. L0213 Pt

Same labels should be used for V1 and V2


NNF attaches yellow patient labels to the following forms:

Informed Consent form 2x, Patient registration form 1x CRF 1x Diary 1x X-ray requisition form 1x Spirometry requisition form 1x Investigator requisition form 2x (V1 + V2) Local lab requisition form 2x (V1 + V2) Sputum results 1x

And to the blue patient pack 1x


Yellow labels for controls 10 labels per control Labels provided for 350 controls per Network Labels consist of Patient Study Number followed by Ctr

e.g. L0214 Ctr

NNF attaches labels to the following forms: Informed Consent form 2x, Patient registration form 1x Control CRF 1x Investigator requisition form 1x Local lab requisition form 1x

And to the white control pack 1x

WP 9-10 GRACE White labels for samples

White labels

Patients

10 labels provided per patient for V1

5 labels provided per patient for V2

Controls

5 labels provided per control for V0

For each visit (V1,V2 and V0) there will be 75 numbers provided

WP 9-10 GRACE White labels for samples

White labels Labels consist of :

‘GRACE’

Patient Study number

Visit Number

e.g. GRACE L0213 V1

GP/Nurse attaches white labels to samples

The remaining labels will be send together with samples to local lab

WP 9-10 GRACE GRACE packs

To be prepared by NNF

Patient packs (blue):

All forms to which yellow labels should be attached

Patient Information Leaflet

TempaDot disposable thermometer (use new ones)

Stamped self adressed envelope for return of patient diary

Sample packs V1 and V2, including besides sample material: Requisition forms (GP and Local Lab) Only for V1 sputum result form White labels

WP 9-10 GRACE GRACE packs

To be prepared by NNF

Control packs (white):

All forms to which yellow labels should be attached

Patient Information Leaflet

Sample pack, including besides the sample material: Requisition forms (GP and Local Lab) White labels


Inclusion flow(for patients and controls)

WP 9-10 GRACEInclusion of Patient or Control (1)

Patient goes to GP

GP checks in- and exclusion criteriaGRACE WP9/10 for patients or controls

and informs patient about study

(Control) Patient signs informedconsent

GP stores informed consent local in(control) patient specific GRACE file

WP 9-10 GRACE Inclusion of Patient or Control (2)

GP/NNF completes registration formon paper GP faxes registration form and IC to NNF

GP/NNF enters registration datawithin 24 hrs into GOS:

GP stores registration form localy in GRACEspecific file

GOS will generate tasks and surveys for eitherControl or Patient based on ‘Subject Type’

WP 9-10 GRACE Inclusion of Patient or Control (3)


Patients flow- Visit 1

WP 9-10 GRACE Patient: Visit 1 (1)

GP takes trial medication outof randomised packs

GP labels the registration form and IC with the trialmedication code label

GP completes CRF GP/NNF enters data into GOS within 2 days


GP/Nurse takes samples of patient:

- 2 nasopharyngeal swabs - 10 ml SST tube of venous blood - EDTA tube of venous blood - Sputum sample

GP/Nurse labelssamples

use V1 labels !

GP/Nurse sends to local lab: - samples - remainng V1 labels - lab requisition form - sputum result form

GP/Nurse completes InvRequisition form

GP/Nurse stores Invrequisition form in GRACE

specific file

GP/Nurse/NNF enters Invrequisition V1 data onto

GOS


GP arranges appointment forX-ray within 3 days

NNF enters result of X-ray into GOS

- GP arranges appointment for patient consultation over 4 weeks

- GP hands out trial medication to patient

- GP hands out diary to patient

X-ray is made and X-ray form iscompleted

WP 9-10 GRACE Patient: Visit 1 DIARY

Patient fills in diary (28 days)

Patient sends diary to NNF NNF enters data of DiaryNNF registers diary into GOS

WP 9-10 GRACE Patient: Visit 1 DIARY/ShortQc

If Patient sends diary NOT to NNF

NNF: - enters first question of Diary into GOS (diary not received) - finalises the survey

GOS will generateShort QC task

NNF enters data of Short QcNNF: - enters first question of Short Qc into GOS (No Short Qc data obtained) - finalises the survey

If NNF fails to contact PatientNNF contacts Patient for Short QC

Diary can be opened againby using the survey listingwhen diary returns later

WP 9-10 GRACE Patient: SAE

GP registers SAE on ‘SAE form’

GP/NNF enters data on ‘SAE form 1’ into GOS within

24 hours

Patient has SAE

GP faxes within 24 hrs SAEform to NNF and confirms with

phone

WP 9-10 GRACE Patient: SAE

After 6 weeks, the SAE task will turn red

If no SAE occured you can delete the SAE task in the following way:- Open SAE survey (using tasklist)- Fill in first question (No SAE occured)- Finalise survey

No new SAE task will be generated

After finalizing SAE form 1 GOS willgenerate the second SAE form

Use this form to register thesecond SAE.

A third SAE should be reporteddirectly to the NNF


Patients flow- Visit 2



- 2 nasopharygeal swabs - 10 ml SST tube of venous blood

GP/Nurse labels samples withsubject code

USE V2 LABELS !

GP performs lung function testing (before salbutamol)

GP registers result on Visit 2‘Spirometry’ form

GP let PT inhale 400 µg salbutamol

GP/Nurse sends to local lab: - samples - remainng V2 labels - lab requisition form

GP/Nurse completesInv requisition form


specific file

GP/Nurse/NNF enters Invrequisition V2 data onto

GOS


GP performs second lung function testing (15 min after salbutamol inhalation) - FEV1 and FVC

GP registers result on‘Spirometry’ form

GP/NNF enters data fromspirometry form into GOS

GP/NNF registeres medicationcapsules present on drug

accountability form

GP/NNF enters number ofcapsules on drug accountabilty

form into GOS


Controls flow- Visit 0

WP 9-10 GRACE Patient: Visit 0

GP completes control CRFGP/NNF enters data from control

CRF into GOS within 2 days


- 2 nasopharyngeal swabs - EDTA tube of venous blood

GP/Nurse labelssamples

use V0 labels !

GP/Nurse sends to local lab: - samples - remainng V0 labels - lab requisition form

GP/Nurse completes InvRequisition form


specific file

GP/Nurse/NNF enters Invrequisition V0 data onto GOS


Samples flow- Visit 0, 1 and 2

WP 9-10 GRACE Samples: Local lab

NNF registers the arrival ofsamples into GOS

Local lab stores local labrequisition form into local binder

Local lab handles and analysesthe samples, labels the new

tubes and stores the samplesuntil transport to central lab

NNF registers sputumresult into GOS

Local lab registers the arrival of samples onlocal lab requisition form

Local lab send sputum resultsto NNF (only V1)

Local lab faxes local labrequisition form to NNF

WP 9-10 GRACE Samples: Central lab

Local lab transports batches ofsamples to central lab

Central lab receives batches ofsamples from local lab

Central lab registers the arrival ofsamples into GOS

Central lab transports batches ofsamples to WP 3-7 labs

Central lab handles the samples,labels the new tubes and stores the

samples until transport to other WP’s

WP 9-10 GRACE Samples: analyses

WP2 stores results central andmerges results to other CRF data

Lab sends local database to WP2

WP lab analyses samples

Lab stores results in localdatabase


Surveys and tasks- Visit 0, 1 and 2

WP 9-10 GRACE Surveys and human tasks on GOS

WP8 WP9-10

Survey tasks

4 8Human tasks

2 19

WP 9-10 GRACE Survey tasks on GOS: Visit 1

GP NNF

CRFX-ray result

Diary

Sample V1registration

Loc Lab

Sputum results

Central lab

Sample V1registrationCentral lab


GP

SAE 1

ShortQc

SAE 2

All surveys for the GP will also appear on thetasklist of the NNF

WP 9-10 GRACE ‘Human’ tasks for NNF: Visit 1

Remind GP Patient CRF

When: 7 days after inclusion, if CRF not finalised

Check samples V1 GP (new)

When: 1 day after inclusion, if sample registration V1 GP not finalised

Register Symptom Diary

When: Direct after inclusion, if Symptom Diary not finalised

Inform Patient about Symptom Diary

When: 4 days after inclusion, if Symptom Diary not finalised

Remind Patient

When: 28 days after inclusion, if Symptom Diary not finalised


GP NNF Central lab

Sprirometryresult

Drugaccountability


Loc Lab



Loc Lab




When: 36 days after inclusion, if sample registration V1 GP not finalised


GP NNF Central lab

Control-CRF


Loc Lab



GP



Remind GP Control CRF (new)

When: 7 days after inclusion, if control CRF not finalised


When: 1 day after inclusion, if sample registration V1 GP not finalised

WP 9-10 GRACE New Survey listing

• Make your selection

• Click on ‘Search’

WP 9-10 GRACE New Survey listing (2)

- Surveys with status ‘new’ will not be shown in survey listing

- Print/view possibility will soon be available

WP 9-10 GRACERemember

• Always include subjects to the correct GP

Each GP should have their own account

• After re-opening a ‘closed’ survey always ‘finalise’ the survey

• When training with GOS use:

The ‘Demo’ network

Subject numbers preceeded with an ‘X’

Trial medication numbers in the range X001- X999

Please, delete your test subjects when you are finished

• Keep up with your tasklist!

WP 9-10 GRACE Tasklist NNF

Direct after inclusion of a Patient


1 week after inclusion of a Patient


6 weeks after inclusion day of a Patient

WP 9-10 GRACECommunication

In case of GOS related questions:

e-mail to Jan-Willem Maaskant ([email protected])

e-mail to Frank Leus ([email protected])

Call the GRACE phone (+31627744069)

WP 9-10 GRACE Online System GRACE Online System WP9-10 Frank Leus 14 September 2007 Stockholm.

Documents

grace white labels

grace yellow labels

yellow patient labels

grace grace packs

grace inclusion of patient

control labels

v2 labels

samples white labels