© Dr Stuart McCully 2013 CHCUK Ltd NIS Considerations - Germany An overview of the considerations when conducting Non-interventional Studies in Germany Stuart McCully • CHCUK Ltd • NIS-C-DE-2013 Version 2 (Dec 2013)
© Dr Stuart McCully 2013CHCUK Ltd
!
NIS Considerations - Germany An overview of the considerations when conducting Non-interventional Studies in Germany !!!Stuart McCully • CHCUK Ltd • NIS-C-DE-2013 Version 2 (Dec 2013) !
© Dr Stuart McCully 2013CHCUK Ltd
NIS Considerations - Germany Version 2 - Dec 2013 !!
Table of Contents !
!Disclaimer 3
Acknowledgement 4
Document History 5
SUMMARY OF CHANGES SINCE PREVIOUS VERSION 5
Study Classification 8
GENERAL CONSIDERATIONS WHEN PLANNING NIS 8
STEP 1 - DETERMINE WHAT TYPE OF STUDY YOU INTEND TO CONDUCT 9
STEP 2 - DETERMINE THE COUNTRY-SPECIFIC REQUIREMENTS 11
STUDY CLASSIFICATION - USEFUL LINKS 12
Regulatory Requirements 13
COUNTRY-SPECIFIC REGULATORY REQUIREMENTS 13
REGULATORY BODIES 13
DEFINITION 15
REGULATORY FRAMEWORK 16
SUMMARY OF THE NIS REQUIREMENTS IN Germany 18
APPROVAL & NOTIFICATION REQUIREMENTS 19
WHO IS RESPONSIBLE FOR WHAT? 21
BFARM GUIDANCE ON NIS 23
REGULATORY SUBMISSIONS ROADMAPS 31
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© Dr Stuart McCully 2013CHCUK Ltd
NIS Considerations - Germany Version 2 - Dec 2013 !!
REGULATORY SUBMISSIONS DOCUMENTS 34
REGULATORY REQUIREMENTS - USEFUL LINKS 35
Study Conduct Considerations 37
APPROVALS AND NOTIFICATIONS 37
STUDY REGISTRATION 43
CONTRACTS 44
DATA PRIVACY & INFORMED CONSENT 47
STUDY COMPLETION ACTIVITIES 48
HUMAN TISSUE RESEARCH 49
STUDY CONDUCT CONSIDERATIONS - USEFUL LINKS 51
Best Practice Considerations 53
PHARMACEUTICAL SELF-REGULATION 53
REQUIREMENTS FOR NON-INTERVENTIONAL STUDIES 53
BEST PRACTICE CONSIDERATIONS - USEFUL LINKS 69
NIS Definitions 71
EUROPEAN NIS DEFINITIONS 71
NIS DEFINITIONS 71
Common NIS Terminology 73
COMMONLY USED NIS TERMS 73
COMMON NIS TERMINOLOGY 73
! !"2
© Dr Stuart McCully 2013CHCUK Ltd
NIS Considerations - Germany Version 2 - Dec 2013 !!!
Disclaimer !
Although this Compilation contains information of a legal nature, it has been developed for
informational purposes only and does not constitute legal advice or opinions as to the current
operative laws, regulations, or guidelines of any jurisdiction. In addition, because new
standards are issued on a continuing basis, this Compilation is not an exhaustive source of all
current applicable laws, regulations, and guidelines relating to non-interventional studies.
While reasonable efforts have been made to assure the accuracy and completeness of the
information provided, researchers and other individuals should check with local authorities
and/or research ethics committees before starting research activities.
!!
! !"3
© Dr Stuart McCully 2013CHCUK Ltd
NIS Considerations - Germany Version 2 - Dec 2013 !!!
Acknowledgement !
My thanks go to Mark Heinemann for his support in researching the updates to the German
Drug Law.
!Acknowledgement: Mark Heinemann, Senior Submission Specialist, Late Stage Group,
inVentiv Health Clinical
!!!!!!!
! !"4
© Dr Stuart McCully 2013CHCUK Ltd
NIS Considerations - Germany Version 2 - Dec 2013 !!!
Document History !
SUMMARY OF CHANGES SINCE PREVIOUS VERSION
Summary of the changes since the previous of the NIS Considerations: Germany report (NIS-
C-DE-2013)
!NOTE: Look for the sections highlighted in the colour on the
left. This is a visual indication that a section has been updated or
is new
Area Impacted Details
Report Format The report has been reformatted to comply with Pages version 5
formatting
Competent Authority
Requirements
The BfArM website was updated/ relaunched on the 15th
November 2013. The impact being:
•All previous hyperlinks needed re-linked
•BfArM has released new FAQs related to the conduct of NIS
(in German only)
a. Refer to page 22
Regulatory Maps The following two new regulatory maps have been added:
1) Multi-Country Mandated Post-Authorisation Safety Studies
(PASS)
1) Germany-Only Mandated Post-Authorisation Safety
Studies (PASS)
! !"5
© Dr Stuart McCully 2013CHCUK Ltd
NIS Considerations - Germany Version 2 - Dec 2013 !!
Legislation New NIS Notification Requirements
The 3rd law amending the German Medicinal Products Act came
into effect on August 13, 2013.
The new regulations are mandatory for all non-interventional
studies with start dates:
•later than 12 Aug. 2013,
•earlier than August 2013 and with an end date later than 31
Dec. 2013.
The new Art. 67 AMG requires the disclosure of "the actual"
compensation paid, paragraph 6 sentence 4 AMG.
The most important changes aim at the disclosure of the actually
paid fees for a physician’s participation in an observational study
and at the reporting requirements for the fees and any payment
updates after study start.
The sponsor must also explain the appropriateness of the
proposed fees in the contract template between sponsor and
physician/site.
!Refer to page 39 for more information
Area Impacted Details
! !"6
© Dr Stuart McCully 2013CHCUK Ltd
NIS Considerations - Germany Version 2 - Dec 2013 !!
!
NIS Guidance The Third Amendment of drug and other regulations of 7 August
2013 ( Federal Law Gazette . I S. 3108) entered into force on 13
August 2013. This amendment brought extensive changes for
the submission requirements for NIS (AWB) into effective. The
BfArM and PEI joint recommendations on the implementation,
planning and analysis of observational studies of 7 July 2010
therefore no longer reflect the current legal status again. The
recommendations will be revised in the near future according to
the new law. Until the publication of the updated
recommendations, the previous recommendations for
information remain available on this website (as per the BfArM
Guidance on NIS).
Pharmaceutical Self
Regulation
The following documents have been amended. The links within
the report have been updated accordingly:
• FSA Code of Conduct on the Collaboration with Healthcare
Professionals (FSA Code of Conduct Healthcare
Professionals) - Nov 2012
• Guidelines by the FSA Board of Management pursuant to
Section 6 Subsection 2 of the FSA Code of Conduct for
Interaction with Healthcare Professionals - August 2013
Extra content has been added in the ‘Best Practice
Considerations, covering:
•Hospitality
•Sweepstakes for Healthcare Professionals
Human Tissue
Research
Added a link to the new German Ethics Council, “Deutscher
Ethikrat” (DE): Opinion on The future of genetic diagnosis –
from research to clinical practice (April 2013)
Area Impacted Details
! !"7
© Dr Stuart McCully 2013CHCUK Ltd
NIS Considerations - Germany Version 2 - Dec 2013 !!!
Study Classification GENERAL CONSIDERATIONS WHEN PLANNING NIS !
!!!!!!!!!!!!!!
! !"8
It Depends!
What are the regulatory
requirements for my NIS?
© Dr Stuart McCully 2013CHCUK Ltd
NIS Considerations - Germany Version 2 - Dec 2013 !!!STEP 1 - DETERMINE WHAT TYPE OF STUDY YOU INTEND TO CONDUCT
Before starting your study you first need to determine what type of study it is:
Is your Study Interventional?
Is your study an interventional clinical trial?
➡ Refer to the Decision tree
!Is your Study a Post-Authorisation Safety Study (PASS)?
Your study is a PASS if the objectives include at least one of the following conditions:
1. Characterization of the safety profile (e.g. identifying the most frequent adverse
reactions in a large population over time);
! !"9
Study !Classification!
Is#your#study#an#interven/onal#clinical#trial?#
Regulatory !Framework!
Interventional?!
PASS?!
Other NIS?!
Clinical Trials Directive !(2001/20/EC)!
Pharmacovigilance Directive !
(2010/84/EU)!
Country Specific!!
Is#your#study#a#post4authoriza/on#safety#study#(PASS)?#
Is#your#study#a#non4safety#related#non4interven/onal#study?#
��
��
��
��
��
© Dr Stuart McCully 2013CHCUK Ltd
NIS Considerations - Germany Version 2 - Dec 2013 !!2. Providing reassurance about the absence of a safety concern related to a specific
adverse reaction;
3. Investigating potential or identified risks, e.g. to characterize the incidence rate,
estimate the rate ratio or rate difference in comparison to a non-exposed population
and investigate risk factors and effect modifiers;
4. Evaluating risks of a product used in authorised indications by patients groups not
studied in the pre-authorisation phase (e.g. pregnant woman, elderly patient);
5. Assessing patterns of drug utilisation and use of the product that may have an impact on
its safety (e.g. co-medication, medication errors);
6. Evaluating the effectiveness of a risk mitigation activity (e.g. drug utilisation study,
patient or physician survey)
!Furthermore, if your study falls within the scope/definition of a PASS and it isn’t a study that
has been required by a Competent Authority as part of your Marketing Authorisation then it is
a ‘voluntary’ PASS. If you are the study sponsor you will need to determine, and document,
what your policy is with regards to the notification and reporting considerations for these
voluntary PASS. The EMA encourages Companies to notify and register these study in the
same way as Obligatory PASS. However, this is currently a business decision.
!Is your study a Non-Safety Related Non-Interventional Study?
If so, the requirements are not standardised and you will need to determine the country-
specific considerations.
!
! !"10
© Dr Stuart McCully 2013CHCUK Ltd
NIS Considerations - Germany Version 2 - Dec 2013 !!STEP 2 - DETERMINE THE COUNTRY-SPECIFIC REQUIREMENTS
The regulatory requirements for ‘Other’ NIS are very much dependent on a number of factors
(see below), which is why there isn’t generally a single answer to the question, “what are the
regulatory requirements for my non-interventional study?”
There are no short cuts. You will need to verify the country-specific regulations and
considerations for each of the countries where you intend to conduct your non-interventional
study.
!
!!
NIS Considerations�
Prospective study?!Retrospective study?!Which countries?!Which patient populations?!Tissue collection?!Tissue export?!Biobanking?!DNA analysis?!Secondary use of data?Secondary use of tissue?!
Notifications!Approvals!Submissions procedures!Registration!Classification!Insurance requirements!
�Other� NIS!Need to verify requirements
for each country!
! !"11
© Dr Stuart McCully 2013CHCUK Ltd
NIS Considerations - Germany Version 2 - Dec 2013 !!STUDY CLASSIFICATION - USEFUL LINKS !
!!
Useful Links Accessed From
Clinical Trials Directive (2001/20/EC) http://ec.europa.eu/health/files/
eudralex/vol-1/dir_2001_20/
dir_2001_20_en.pdf
Pharmacovigilance Directive (2010/84/
EU)
http://ec.europa.eu/health/files/
eudralex/vol-1/dir_2010_84/
dir_2010_84_en.pdf
EMA Good Pharmacovigilance Practices
(GVP)
http://www.ema.europa.eu/ema/
index.jsp?curl=pages/regulation/
document_listing/
document_listing_000345.jsp&mid=WC0
b01ac05804fcdb1
EMA Guidance on the 2010
Pharmacovigilance Legislation
http://www.ema.europa.eu/ema/
index.jsp?curl=pages/regulation/general/
general_content_000492.jsp&mid=WC0b
01ac058033e8ad
! !"12
© Dr Stuart McCully 2013CHCUK Ltd
NIS Considerations - Germany Version 2 - Dec 2013 !!!
Regulatory Requirements COUNTRY-SPECIFIC REGULATORY REQUIREMENTS !
REGULATORY BODIES
Competent Authority Paul-Ehrlich-Institute, the Federal
Institute for Vaccines and Biomedicines
(PEI)
or
The Federal Institute for Drugs and
Medical Devices (BfArM)
Research Ethics Committees Germany has a total of 53 research ethics committees (RECs)
Data Protection Agency Der Bundesbeauftragte für den
Datenschutz und die Informationsfreiheit
(BFDI)
(The Federal Commissioner for Data
Protection and Freedom of Information)
Pharmaceutical Self-Regulation Body The Association of Research-Based Pharmaceutical Companies (vfa)
! !"13
© Dr Stuart McCully 2013CHCUK Ltd
NIS Considerations - Germany Version 2 - Dec 2013 !!
!
Pharmaceutical Code of Practice • FSA Code of Conduct on the
Collaboration with Healthcare
Professionals (FSA Code of Conduct
Healthcare Professionals) - Nov 2012
• Guidelines by the FSA Board of
Management pursuant to Section 6
Subsection 2 of the FSA Code of
Conduct for Interaction with
Healthcare Professionals - August 2013
! !"14
© Dr Stuart McCully 2013CHCUK Ltd
NIS Considerations - Germany Version 2 - Dec 2013 !!DEFINITION
Non-Interventional Trial
A non-interventional trial is a study, in the context of which findings resulting from persons'
treatment with medicinal products pursuant to the specifications for use contained in the
marketing authorisation are analysed using epidemiological methods; the treatment,
including the diagnosis and monitoring shall not follow a predetermined trial protocol but
shall result exclusively from current medical practice (as per Section 4(23) of the German
Drug Law (AMG)).
!Non-Interventional Study
Non-interventional studies, to which drug monitoring projects also belong, are prospective
studies with the purpose of gaining new insights from the treatment of patients on the
application of pharmaceuticals in accordance with the instructions laid down in the marketing
authorisation (e.g., harmlessness or efficacy of pharmaceuticals) (as per Section 19.1 of the
FSA Code of Practice).
The principle of non-intervention applies to all therapeutic and diagnostic measures. The
inclusion and treatment, including the diagnosis and supervision, do not therefore follow a
previously laid down study plan, but solely the physicians medical practise. The decision to
include a patient in a non-interventional study has to be clearly separated from the decision on
the prescription of a medicinal product. The data obtained has to be evaluated by means of
epidemiological methods (as per Section 19.1 of the FSA Code of Practice).
!!
! !"15
© Dr Stuart McCully 2013CHCUK Ltd
NIS Considerations - Germany Version 2 - Dec 2013 !!BFARM GUIDANCE ON NIS
What studies are considered observational studies ( AWB )?
Observational studies are studies that are intended to gather information on the application of
authorized or registered medicinal products. Observational studies are a sub-category of non-
interventional trials within the meaning of § 4, paragraph 23, sentence 3 German Drug Law
( AMG ), ie investigations, under which "findings from the treatment of people with drug
using epidemiological methods are analyzed here follows the treatment, including diagnosis
and monitoring is not a pre-defined test plan, but only the medical practice in so far as it is a
registrable or under § 21a paragraph 1 AMG is subject to approval medicines, this also takes
place under the conditions laid down in the authorization or approval of such information for
his application "The decision. to include the patient in an observational study, is separate
from the decision on the prescription of the medicine (as per the BfArM FAQs Relating to
NIS).
An observational study is not a clinical examination according to § 23 paragraph 4 sentence 1
AMG and is therefore not subject to approval. But it is according to § 67 paragraph 6 AMG
the physicians' federal associations, the Central Federal Association of Health Insurance, the
Association of Private Health Insurance Association show and the competent higher federal
authority immediately. No observational studies are studies in humans after the approval of
the drug, which are intended to explore clinical or pharmacological effects of drugs or to
detect or identify side effects or to study absorption, distribution, metabolism, or excretion
and carried out with the aim to be, to convince themselves of the safety or effectiveness of the
drug, and in which the treatment of patients, including diagnosis and monitoring goes beyond
the usual medical practice . Such are 23 sentence 1 as clinical examinations according to § 4
paragraph AMG perform. Characteristics of a clinical trial are eg a systematic allocation of
patients to treatment arms in terms of randomization and the use of medicines outside the
approved indication. These clinical trials are to be approved before the start of the competent
higher federal authority and to assess positively by the appropriate ethics committee. An
authorization by the competent higher federal authority and the favorable opinion of the
Ethics Committee are also clinical trials within the approved indication, so-called Phase IV
tests, required (as per the BfArM FAQs Relating to NIS).
! !"23
© Dr Stuart McCully 2013CHCUK Ltd
NIS Considerations - Germany Version 2 - Dec 2013 !!!
Study Conduct Considerations CONSIDERATIONS WHEN CONDUCTING NIS IN GERMANY
!
APPROVALS AND NOTIFICATIONS
Competent Authority (BfArM/PEI)
Authorisation by the Competent Authority (BfArM/PEI)
There is currently no requirement for NIS to be approved by BfArM/PEI.
!Notifying the Competent Authority (BfArM/PEI)
Before starting any NIS, the Sponsor of the study should notify BfArM/PEI (as per Section
67(6) of the German Drug Law (AMG).
At present there is no official notification; the notification of an NIS to the Competent
Authority should be submitted informally and should state (Refer to the BfArM FAQs and the
BfArM and PEI NIS Recommendation July 2010 – In German): 1
The time and location of the NIS
The purpose of the NIS
!
! !"37
! The Third Amendment of drug and other regulations of 7 August 2013 ( Federal Law Gazette . I S. 3108) entered into force on 13 August 1
2013. This amendment brought extensive changes for the submission requirements for NIS (AWB) into effective. The BfArM and PEI joint
recommendations on the implementation, planning and analysis of observational studies of 7 July 2010 therefore no longer reflect the
current legal status again. The recommendations will be revised in the near future according to the new law. Until the publication of the
updated recommendations, the previous recommendations for information remain available on this website (as per the BfArM Guidance on
NIS).
© Dr Stuart McCully 2013CHCUK Ltd
NIS Considerations - Germany Version 2 - Dec 2013 !!!
Best Practice Considerations BEST PRACTICE CONSIDERATIONS WHEN CONDUCTING NIS IN GERMANY
!
PHARMACEUTICAL SELF-REGULATION
Pharmaceutical Self-regulation Body (vfa)
The Association of Research-Based Pharmaceutical Companies (vfa) is the trade
organizations of research-based pharmaceutical companies in Germany that is affiliated with
EFPIA and represents more than two-thirds of the German pharmaceutical market.
For clarification (and to avoid confusion), the FSA or “Freiwillige Selbstkontrolle für die
Arzneimittelindustrie e.V.” is the Association of Voluntary Self-regulation for the
Pharmaceutical Industry and represents members of the Pharmaceutical Industry, Healthcare
Professionals and Patient Organisations. As such, the FSA is not a member of EFPIA.
The FSA can be considered as a control body supervising that ethical rules are respected in
Germany regarding interactions between the above mentioned stakeholders.
!REQUIREMENTS FOR NON-INTERVENTIONAL STUDIES
Non-interventional studies (NIS) describe all forms of pharmaceutical studies in which
physicians are not provided with treatment requirements: They can include any patients for
whom they prescribe the pharmaceutical in question. Apart from that, it is completely in their
discretion how they treat the patients. The administration of the pharmaceutical is the full
responsibility of the patient. This is different for clinical studies as required for the marketing
authorization of pharmaceuticals: There are strict selection criteria for patients eligible for
participation; for example, in most cases, patients who suffer from concomitant diseases will
not be able to participate. The study plan clearly declares which concomitant treatments are
! !"53
© Dr Stuart McCully 2013CHCUK Ltd
NIS Considerations - Germany Version 2 - Dec 2013 !!permissible and which are not. Furthermore, the pharmaceutical administration is monitored
by physicians and nursing staff (as per the vfa guidance - 2007).
During the post-marketing surveillance study as the most frequent NIS, many "treatment
cases" with a certain drug are documented by physicians, and these records are evaluated by
the manufacturer. This way, pharmaceutical companies can obtain information e.g. on very
rare side effects and the drugs' reliability even if therapy compliance is not optimal (as per the
vfa guidance - 2007).
"Post-marketing surveillance studies are an indispensable instrument in pharmaceutical
research," Yzer said. In this respect, the VFA also agrees with the German Federal Institute
for Drugs and Medical Devices (BfArM). Nevertheless, post-marketing surveillance studies
have become the target of criticism. To counter this situation, the VFA has developed the
following core recommendations:
Within the company, non-interventional studies are within the scope of responsibility
of the head of the medical department, both from an organizational and a budgetary
standpoint. Employees from other departments may participate but will be reporting to
the head of the medical department.
For each NIS, a consultation with one of the German ethics commissions must be
obtained.
After being educated, all patients included in an NIS must consent to participating in
the study in writing.
At the start of the study, information is entered into a publicly accessible online
register.
A summary of the study results must be published no later than 12 months after
completion of the NIS.
Other aspects are already clearly governed by the "Recommendations for the Planning,
Execution and Evaluation of Post-Marketing Surveillance Studies" by BfArM and the Code of
Conduct of the Voluntary Self-Regulation of the Pharmaceutical Industry (FSA). Both BfArM
and the Code suggest orienting the compensation on the fee scale for physicians. All post-
! !"54
© Dr Stuart McCully 2013CHCUK Ltd
NIS Considerations - Germany Version 2 - Dec 2013 !!!
NIS Definitions Considerations when providing access to unapproved drugs
EUROPEAN NIS DEFINITIONS !
NIS DEFINITIONS
Non-interventional Study (NIS)
A non-interventional study is a study fulfilling cumulatively the following requirements:
The medicinal product is prescribed in the us
ual manner in accordance with the terms of
the marketing authorisation;
The assignment of the patient to a particular
therapeutic strategy is not decided in
advance by a trial protocol but falls within
current practice and the prescription of the
medicine is clearly separated from the
decision to include the patient in the study; and
No additional diagnostic or monitoring procedures are applied to the patients and
epidemiological methods are used for the analysis of collected data.
Non-interventional studies are defined by the methodological approach used and not by the
scientific objectives. Non-interventional studies include database research or review of
records where all the events of interest have already happened (e.g. case-control, cross-
sectional and cohort studies). Non-interventional studies also include those involving primary
data collection (e.g. prospective observational studies and registries in which the data
collected derive from routine clinical care), provided that the conditions set out above are
met.
! !"71
© Dr Stuart McCully 2013CHCUK Ltd
NIS Considerations - Germany Version 2 - Dec 2013 !!In this context, interviews, questionnaires and blood samples may be performed as normal
clinical practice.
(as per Section A of EMA GVP Module VIII, Rev 1 - April 2013)
!Post-authorisation Safety Study (PASS)
Any study relating to an authorised medicinal product conducted with the aim of identifying,
characterising or quantifying a safety hazard, confirming the safety profile of the medicinal
product, or of measuring the effectiveness of risk management measures (Article 1(c)(15) as
2001/83/EC as amended by Directive 2010/84/EU)
!Post-authorisation Efficacy Studies (PAES)
Any study conducted where concerns relating to some aspects of the efficacy of the medicinal
product are identified and can only be resolved after the medicinal product has been marketed
(Article 21(a) as 2001/83/EC as amended by Directive 2010/84/EU)
!!!!
! !"72
© Dr Stuart McCully 2013CHCUK Ltd
NIS Considerations - Germany Version 2 - Dec 2013 !!!
Common NIS Terminology COMMONLY USED NIS TERMS !
COMMON NIS TERMINOLOGY
Acronym Term
AE Adverse Event
AR Adverse Reaction
CA Competent Authority (e.g., MHRA)
CI Chief Investigator
CRA Clinical Research Associate
CRF Case Report Form
CRO Contract Research Organisation
CSR Clinical Study Report
CTD Clinical Trials Directive (2001/20/EC)
CV Curriculum Vitae
DPA Data Protection Agency
EFPIA European Federation of Pharmaceutical Industries and Associations
GCP Good Clinical Practice
GPP Good Pharmacoepidemiology Practice
GVP Good Pharmacovigilance Practice
ICF Informed Consent Form
! !"73
© Dr Stuart McCully 2013CHCUK Ltd
NIS Considerations - Germany Version 2 - Dec 2013 !!
ICH The International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use
ICH GCP ICH Good Clinical Practice Guidelines
IEC Independent Ethics Committee
IMP Investigational Medicinal Product
ISF Investigator Site File
ISPE International Society of Pharmacoepidemiology
MA Marketing Authorisation
MAH Marketing Authorisation Holder
NCA National Competent Authority
NIS Non-interventional Study
NTF Note to the File
PAS Post-authorisation Study
PAES Post-authorisation Efficacy Study
PASS Post-authorisation Safety Study
PI Principal Investigator
PIL Patient Information Leaflet
PV Pharmacovigilance
QA Quality Assurance
QC Quality Control
QMS Quality Management System
QoL Quality of Life
QP Qualified Person
Acronym Term
! !"74
© Dr Stuart McCully 2013CHCUK Ltd
NIS Considerations - Germany Version 2 - Dec 2013 !!
!!
REC Research Ethics Committee
SAE Serious Adverse Event
SAR Serious Adverse Reaction
SDV Source Data Verification
SIF Subject Information Form
SmPC Summary of Product Characteristics
SOP Standard Operating Procedure
SUSAR Suspected Unexpected Serious Adverse Reaction
TMF Trial Master File
WMA World Medical Association
Acronym Term
! !"75