This document provides an overview of the key responsibilities of sponsors and contract research organizations (CROs) in clinical trials. It discusses CRO responsibilities in areas such as regulatory affairs, project management, clinical operations, biometrics, medical writing, pharmacovigilance, and quality assurance. For each area, it briefly outlines some of the main tasks involved, such as regulatory submission and approval, clinical monitoring, statistical analysis, safety reporting, and ensuring compliance with Good Clinical Practice standards. The overall purpose is to define the roles that CROs take on to assist sponsors in managing various aspects of clinical research.

1. GCP Workshop: Sponsor/CRO Responsibilities
Hanaa Abdel-Maguid
TCD MENA © 2017 1

2. TCD MENA © 2017 2
TCD MENA © 2017 2
 GCP Definition
 Sponsor/CRO Responsibilities
 Regulatory Affairs
 Project Management
 Clinical Operations
 Biometrics
 Medical Writing
 Pharmacovigilance
 Quality Assurance
Contents

3. TCD MENA © 2017 3
GCP
Definition

4. TCD MENA © 2017 4
TCD MENA © 2017 4
 Definition
A person or an organization (commercial, academic, or other)
contracted by the sponsor to perform one or more of a sponsor's trial-
related duties and functions. ICH-GCP E6 (R2) § 1.2
 CRO Responsibilities:
 Implement systems and procedures for conduct of and assessment
of safety in clinical trials
 Conduct CTs in accordance with the applicable regulations and
guidelines
 Abide by contract signed with the sponsor
 Communicate concerns to the sponsor in a timely manner
 Maintain accurate records
Contract Research Organization (CRO)

5. TCD MENA © 2017 5
5
Pharmacovigilance
& Safety Reporting
Medical & Biometrics
Services
Regulatory
Affairs
CRO Responsibilities
TCD MENA © 2017
Project Management
& ClinOps

6. TCD MENA © 2017 6
TCD MENA © 2017 6
Regulatory
Affairs

7. TCD MENA © 2017 7
TCD MENA © 2017 7
 Clinical trials should be conducted in accordance with the ethical
principles that have their origin in the Declaration of Helsinki, and that
are consistent with GCP and the applicable regulatory requirement(s).
(ICH GCP E6(R2) § 2.1
 The role of RA department is to ensure compliance (in relation to
trials) Adherence to all the trial-related requirements, Good Clinical
Practice requirements, and the applicable regulatory requirements.
(ICH GCP E6(R2) § 1.15
 This compliance is maintained by performing several activities in
Consequential manner.
Regulatory Authority

8. TCD MENA © 2017 8
TCD MENA © 2017 8
Regulatory Affairs Activities
1- Receipt of all Study Documents
2- Study Documents Country Adaptations
3- Translation & Verification (for any document handed to
patients)
4- EC Submission & EC approval.
5- RA Submission & RA approval.
6- Concerned authorities submission and approval (in case
of biological samples exportation).
7- Investigator Budget negotiation/ Contracts Execution
8- Import License submission & approval.
9- MOH Clearance Authorization submission & approval.
10-IMP delivery to sites & Site initiation.

9. TCD MENA © 2017 9
TCD MENA © 2017 9
Project
Management

10. TCD MENA © 2017 10
TCD MENA © 2017 10
 Vendor Management and Qualification
 Translation
 Laboratories
 Radiology
 Drug Depot
 Contracting (Sponsor, investigator, Vendor)
A written, dated, and signed agreement between two or more involved parties
that sets out any arrangements on delegation and distribution of tasks and
obligations and, if appropriate, on financial matters. The protocol may serve as
the basis of a contract. ICH-GCP E6 (R2) § 1.17
Clinical Project Management

11. TCD MENA © 2017 11
TCD MENA © 2017 11
 Project Oversight:
 Ensure the interim and final project deliverables meet the sponsor’s
time, quality, and cost expectations;
 Provide leadership, co-ordination and management of the project
team through start up, conduct, tracking, quality and regulatory
compliance and close-out activities;
 Complete and monitor actual hours and expenses versus budget
 Review and approve costs and ensure timely invoicing.
Clinical Project Management

12. TCD MENA © 2017 12
TCD MENA © 2017 12
Monitoring Plan
Communication Plan
Risk Management Plan
Safety Plan
CRF completion
guidelines
Data Management Plan
Clinical Project Plans

13. TCD MENA © 2017 13
TCD MENA © 2017 13
Clinical
Operations
Management

14. TCD MENA © 2017 14
TCD MENA © 2017 14
Clinical Ops. Activities
• Site Selection
(FQ)
• Pre-Study Visit
(PSVs)
Start Up
• Study Site
Initiation
• Clinical
Monitoring
• Monitoring
Report
Study
Conduct
• Close Out Visits
Study
Closure

15. TCD MENA © 2017 15
TCD MENA © 2017 15
Clinical Monitoring
 Monitor's Responsibilities
The monitor(s) in accordance with the sponsor’s requirements should
ensure that the trial is conducted and documented properly by carrying
out the necessary activities when relevant and necessary to the trial
and the trial site: ICH-GCP E6 (R2) § 5.18.4

16. TCD MENA © 2017 16
IRB/IEC
APPROVAL
OPINION
SUBJECT
ENROLLMENT
MONITORING VISITS
During the monitoring visits, the
Monitor will verify:
COMPLIANCE
with GCP and
PROTOCOL
IP DISPENSING
&
ACCOUNTABILITY
ADVERSE
EVENT
REPORTING
CRF
COMPLETION
vs SOURCE
DOCUMENTS
S F
T I
U L
D E
Y
STUDY
INITIATION
that the Investigator maintains the
essential documents (ICH/GCP § 5.18.4)
S F
T I
U L
D E
Y
Clinical Monitoring
TCD MENA © 2017 17

17. TCD MENA © 2017 17
CRF
CRF
CRF DRF
code breaking material
OTHER
MATERIALS INVESTIGATOR’s
FILE ARCHIVE
to ensure that :
all SAEs have been
reported to the
Sponsor
all CRFs have been
verified against
source documents
all queries have been
resolved by the
Investigator
all unused drugs
have been returned to
the Sopnsor for
destruction, and all
decoding envelopes
have been retrieved
all unused
materials
have been
retrieved
from the
study site
all essential documents
have been maintained by
the Investigator
all arrangements for
archiving have been made
by the Investigator
CLOSURE VISIT TASKS
18TCD MENA © 2017

18. TCD MENA © 2017 18
19
Biometrics &
Medical Writing
TCD MENA © 2017

19. TCD MENA © 2017 19
TCD MENA © 2017 19
Biometrics & Medical Writing Process
Protocol
writing
CRF Design
Informed
Consent
Development
Statistical
Analysis Plan
Edit Checks
Development
Database
Design
Data
Management
Plan
Data
Validation
Process
Query
Management
Data
Cleaning
Database
Lock
Medical
Coding
Statistical
Analysis
Report
Clinical
Study Report
Manuscript

20. TCD MENA © 2017 20
TCD MENA © 2017 20
Biometrics & Medical Writing
 Informed Consent
A Process by which a subject voluntarily confirms his or her willingness
to participate in a particular trial, after having been informed of all
aspects of the trial that are relevant to the subject’s decision to
participate. Informed consent is documented by means of a written,
signed and dated informed consent form. ICH GCP E6(R2) § 1.28

21. TCD MENA © 2017 21
TCD MENA © 2017 21
Medical Writing
 Protocol
A clinical trial protocol is a document that describes the objective(s),
design, methodology, statistical considerations, and organization of a
trial. Detail on the background of and rationale for the trial is usually
included in the protocol, although this information could be provided in
other protocol referenced documents., use the term protocol to refer to
the protocol and protocol amendment(s). ICH GCP E6 (R2) §1.44

22. TCD MENA © 2017 22
TCD MENA © 2017 22
Medical Writing
 Clinical Study Reports (CSR)
A written description of a trial/study of any therapeutic, prophylactic, or
diagnostic agent conducted in human subjects, in which the clinical and
statistical description, presentations, and analyses are fully integrated
into a single report. ICH GCP E6 (R2) § 1.13
 Manuscripts
A final document in the clinical trial that is written according to specific
guidelines for publication purpose.

23. TCD MENA © 2017 23
TCD MENA © 2017 23
Biostatistics
 Statistical Analysis Plan (SAP):
A document that contains a more technical and detailed elaboration of
the principal features of the analysis described in the protocol, and
includes detailed procedures for executing the statistical analysis of the
primary and secondary variables and other data.
 Statistical Analysis Report (SAR)
A report that contains the statistical analysis of the primary and
secondary variables and other data according to the study protocol.

24. TCD MENA © 2017 24
TCD MENA © 2017 24
Data Management
 Case Report Form Design (CRF)
A printed, optical, or electronic document designed to record all of the
protocol required information to be reported to the sponsor on each trial
subject. ICH GCP E6 (R2) §1.11
 Database Design
An electronic form designed according to the approved CRF for storing
data from a clinical trial in an organized format.

25. TCD MENA © 2017 25
TCD MENA © 2017 25
Data Management
 Data Management Plan Development
A document to facilitate forward planning of all data management activities,
provide technical information and act as a reference document for auditors
or retrospective retrieval of data.
 Data Validation Process
A process to ensures that the data are complete, valid and consistent.
 Query Management
A process of raising queries for incomplete, invalid of inconsistent data for
investigators resolutions and update the database accordingly.

26. TCD MENA © 2017 26
TCD MENA © 2017 26
Data Management
 Medical Coding
A process coding the Adverse events and concomitant medications
according to Medical dictionaries (MedDRA, WHO Drug)
 Data Cleaning
A process that grants that all the data have been entered, queries have
been raised by the Data management and resolved by the investigator in
order to proceed with database lock and start the Statistical Analysis
process.

27. TCD MENA © 2017 27
TCD MENA © 2017 27
PV/Safety Reporting

28. TCD MENA © 2017 28
TCD MENA © 2017 28
Pharmacovigilance &Safety Monitoring
 Safety Monitor is responsible for immediate and follow-up reporting of
any SAEs to sponsor/ RA according to the safety reporting timelines
 The immediate reports should be followed promptly by details, written
reports.
 The immediate and follow-up reports should identify subjects by unique
code numbers assigned to the trial subjects rather than by the subjects’
name, personal identification numbers, and/or addresses. ICH GCP E6
(R2) § 4.11

29. TCD MENA © 2017 29
TCD MENA © 2017 29
Pharmacovigilance &Safety Monitoring
 Adverse events and/or laboratory abnormalities identified in the protocol
as critical to safety evaluations should be reported to the sponsor
according to the reporting requirements and within the time periods
specified by the sponsor in the protocol.
 For reported deaths, the investigator should supply the sponsor and the
IRB/EC with any additional requested information.
 The investigator should also comply with the applicable regulatory
requirements related to the reporting of unexpected serious adverse
drug reactions to the regulatory authority(ies) and the IRB/EC
ICH GCP E6 (R2) § 4.11

30. TCD MENA © 2017 30

31. TCD MENA © 2017 31
Quality Assurance
• Staff Training
• Systems, procedures and working
practices
• Compliance ICH GCP, SA GCP, FDA
…etc.
• Internal project-specific and system
audits
Internal
Functions
• Contracted trial site, laboratory &
other vendors
• QA/training services (e.g. site
training, GCP training)
External
Functions

32. THANK YOU
WWW.TCD-GLOBAL.COM
TCD MENA © 2017 32