This document provides an overview of Good Clinical Practice (GCP) guidelines for clinical research professionals. It begins with a brief history of GCP and clinical trials, highlighting milestones such as the Nuremberg Code, Declaration of Helsinki, and ICH harmonized guidelines. The rest of the document outlines the key principles of ICH GCP, roles and responsibilities of investigators, sponsors, and ethics committees, and requirements for trial protocols, documentation, and compliance.

1. ACS_GCP_Version 1.0
Catered for professionals within clinical research; Investigators,
Research Nurses, Monitors or other staff active in clinical research

2. ACS_GCP_Version 1.0
Agenda
• History of GCP
• GCP Regulations
• Principles of ICH E6
• E6 (R2) Addendum
• Computer Systems
• Common Compliance Issues

3. ACS_GCP_Version 1.0
History of GCP
Clinical trials have a long and rich history
• 1537 - A Renaissance surgeon, Ambroise Pare,
unintentionally carried out a clinical trial when he ran
out of the standard treatment of boiling oil for open
wounds. He mixed egg yolk, turpentine and oil of rose
and soon noticed that the wounds treated with this
mixture healed well as compared to those wounds that
became swollen and infected with the standard
treatment.
• 1747 - James Lind conducted the first controlled clinical
trial on a group of sailors suffering from scurvy. He
placed them all on the same diet, but fed one group
additional items such as cider and vinegar and fed the
other group lemon juice. The group who had the lemon
juice supplement recovered from scurvy in just six days.

4. ACS_GCP_Version 1.0
History of GCP
 1863 - Placebos are first used in clinical trials. Placebos are non-
effective medical treatments given to control groups to compare the
results with those from the new drug.
 1923 - Randomization is introduced to clinical trials. Randomization
involves participants randomly receiving one of the treatments, one
being a placebo and one being the new drug. Blind clinical trials,
where neither group knows which treatment they are receiving, also
emerged in the 20th century.
 1944 - Multicenter clinical trials are introduced, where multiple studies
are conducted at various sites all using the same protocol to provide
wider testing and better statistical data.

5. ACS_GCP_Version 1.0
History of GCP
The Nuremberg Code - A huge step forward in medical
ethics took place in Germany in 1947. The Nuremburg
code was formulated in response to the World War II
medical atrocities. The Code was based on a
memorandum by Dr. Andrew Ivy and described ten
research ethics principles for human experimentation.
These principles stated that the "voluntary consent of the
human subject is absolutely essential" and also included
other principles such as; the patient being able to end the
experiment at any time, and that all safety precautions
are to be taken to limit pain and suffering.

6. ACS_GCP_Version 1.0
History of GCP
The Declaration of Helsinki - Following on from these
new regulations the World Medical Association formally rearticulated
these principles in 1964, outlining ethical codes for physicians and
protection of participants in clinical studies all over the world. This was
known as the Declaration of Helsinki, and is still looked upon today as
the foundation of modern medical ethics.

7. ACS_GCP_Version 1.0
History of GCP
1960s
 Mid-century high profile cases lead to further change - it took several high profile
public health disasters for researchers to fully comprehend and enforce the ideas of medical
ethics. One of the first and most well-known tragedies surrounded the use of Thalidomide,
which was a widely used drug for the treatment of nausea in pregnant women in the late
1950s and early 1960s. It became evident in the 1960s that thalidomide had not been
properly assessed before market and treatment with thalidomide could cause severe birth
defects in children. Thalidomide use in pregnant women was banned in most countries at
that time but thalidomide did go on to be a useful treatment for leprosy and later, multiple
myeloma.
 The thalidomide tragedy marked a turning point in toxicity testing, as it prompted the
United States and international regulatory agencies to develop systematic toxicity testing
protocols . The subsequent study of thalidomide and its effects on developmental biology
led to important discoveries in the biochemical pathways involved in limb development.
Recent research on thalidomide and its mechanisms of action is leading to a better
understanding of its molecular targets and with an improved understanding of
these targets, safer drugs may be designed.

8. ACS_GCP_Version 1.0
History of GCP
1970s
 Another very public example of research ethics gone wrong was the notorious
Tuskegee study. The study, which was titled "Tuskegee Study of Untreated Syphilis in
the Negro Male“ was an infamous clinical study conducted between 1932 and 1972 by
the U.S. Public Health Service, it involved studying the natural progression of
untreated syphilis in rural African-American men in Alabama under the auspices of
receiving free health care from the government.
 This ‘study’ which lasted 40 years, was extremely controversial: the researchers
knowingly kept the study going for many years after penicillin had been validated as
an effective treatment for the very syphilis the study was monitoring. Local officials
turned whistle-blowers leaked the information to the press in the 1970s, this led to
changes is US law concerning the treatment of participants on studies and the
ethical standards to be followed by all researchers.

9. ACS_GCP_Version 1.0
History of GCP
1990s
 An international standard - Moving into the 1990s, the next great leap forward in
clinical trial safety took place in 1996 in Brussels. The International Conference on
Harmonisation of Technical Requirements for Registration of Pharmaceuticals for
Human Use (ICH) issued guidelines for Good Clinical Practice (GCP) to help
eliminate differences in drug development requirements for three global
pharmaceutical markets: The EU, Japan and U.S.
 ICH-GCP is a harmonised international standard that "protects the rights, safety
and welfare of human subjects, minimises human exposure to investigational
products, improves quality of data, speeds up marketing of new drugs and decreases
the cost to sponsors and to the public."
 Currently all clinical studies worldwide must adhere to ICH-GCP if the results are to
be published or the data considered by any major national drug authorisation
board.

10. ACS_GCP_Version 1.0
History of GCP
2001
 ICH GCP evolved from an economic incentive to a legal requirement in
Europe. Directive 2001/20/EC, commonly known as „The Clinical Trials
Directive‟. Came into force in all European member states in May 2004
2005
 Directive 2005/28/EC. Commonly known as “The GCP Directive”. Came into
force in all European member states in Jan 2006
2014
 Regulation 536/2014. “The Clinical Trial Regulation”. Applies from May 28th
2016.

11. ACS_GCP_Version 1.0
Regulations relating to GCP - EU
 Directive 2001/20/EC – implementation of GCP in conduct of clinical
trials on medicinal products for human use
 Directive 2005/28/EC – detailed guidelines for GCP as regards IMP for
human use
 Directive 2003/94/EC – principles and guidelines of GMP in respect of
medicinal products for human use and IMP for human use
 Regulation 536/2014 (not yet applicable)

12. ACS_GCP_Version 1.0
Regulations relating to GCP - US
 Electronic Records; Electronic Signatures (21 CFR Part 11)
 Protection of Human Subjects (Informed Consent) (21 CFR Part 50)
 Financial Disclosure by Clinical Investigators (21 CFR Part 54)
 Institutional Review Boards (21 CFR Part 56)
 Investigational New Drug Application (21 CFR Part 312)

13. ACS_GCP_Version 1.0
Regulations relating to GCP - US
 Foreign Clinical Trials not conducted under an IND (21 CFR Part 312.120)
 Forms 1571 (Investigational New Drug Application) and 1572 (Statement of
Investigator)
 Applications for FDA Approval to Market a New Drug (21 CFR Part 314)
 Bioavailability and Bioequivalence Requirements (21 CFR Part 320)
 Applications for FDA Approval of a Biologic License (21 CFR Part 601)

14. ACS_GCP_Version 1.0
Regulations relating to GCP - RoW

15. ACS_GCP_Version 1.0
Good Clinical Practice (GCP)
 ICH E6
 provides a unified standard for the European Union (EU), Japan,
and the United States
 facilitates the mutual acceptance of clinical data by the
regulatory authorities in these jurisdictions
 applicable to drug and biological products

16. ACS_GCP_Version 1.0
What does it mean?
 The Code of Federal Regulation is law in US and non-compliance can
in worst case be handled as a criminal offence
 In Europe the directives and associated GCP regulations have been
(country specific) laws since 2004
 In Japan GCP is law as stated in MHW Ministerial Ordinance No.28
(Mar.27,1997), No.106 (Jun.12, 2003), No.72 (Mar.31, 2006), No.24
(Feb.29, 2008) & No 161 (Dec 28, 2012)

17. ACS_GCP_Version 1.0
ICH Guideline for GCP - Introduction
 Good clinical practice (GCP) is an international ethical and scientific
quality standard for designing, conducting, recording, and reporting
trials that involve the participation of human subjects.
 Compliance with this standard provides public assurance that the
rights, safety, and wellbeing of trial subjects are protected, consistent
with the principles that have their origin in the Declaration of
Helsinki, and that the clinical trial data are credible.

18. ACS_GCP_Version 1.0
ICH Guideline for GCP - Table of
Contents
 Glossary
 The Principles of ICH GCP
 Institutional Review Board / Independent Ethics Committee
 Investigator
 Sponsor
 Clinical Trial Protocol and Protocol Amendments
 Investigator‟s Brochure
 Essential Documents for the Conduct of a Clinical Trial

19. ACS_GCP_Version 1.0
Good Clinical Practice – The principles
of ICH GCP
 2.1: 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
requirements.
 2.2: Before a trial is initiated, foreseeable risks and inconveniences
should be weighed against the anticipated benefit for the individual
trial subject and society. A trial should be initiated and continued only
if the anticipated benefits justify the risks.
 2.3: The rights, safety and well being of trial subjects shall prevail over
the interests of science and society: ◦ Informed Consent ◦ Ethics
Committees ◦ Records of Adverse Events

20. ACS_GCP_Version 1.0
Good Clinical Practice – The
principles of ICH GCP
 2.4: The available nonclinical and clinical information on an
investigational product should be adequate to support the proposed
clinical trial: ◦ Investigator‟s Brochure
 2.5: Clinical trials should be scientifically sound and described in a
clear, detailed protocol: ◦ Input from external medical experts ◦ Input
from internal medical experts and statisticians ◦ Reviewed and
accepted by regulatory authorities
 2.6: A trial should be conducted in accordance with the protocol that
has received prior institutional review board (IRB) / independent
ethics committee (IEC) approval / favourable opinion: ◦ “Regulatory”
Green Light.

21. ACS_GCP_Version 1.0
Good Clinical Practice – The principles
of ICH GCP
 2.7: The medical care given to, and medical decisions made on behalf
of, subjects should always be the responsibility of a qualified physician
or, when appropriate, of a qualified dentist: ◦ Principal Investigator
(PI) ◦ Sub-investigator
 2.8: Each individual involved in conducting a trial should be qualified
by education, training and experience to perform his or her respective
tasks:
◦ Maintain: ─ Job description, CV, Training record.
◦ Perform: ─ Activities in which you are trained and for which you have
documentation.

22. ACS_GCP_Version 1.0
Good Clinical Practice – The
principles of ICH GCP
 2.9: Freely given informed consent should be obtained from every subject
prior to clinical trial participation.
◦ Information should contain details concerning Data Privacy and potential
transfer of data outside EU
 210: All clinical trial information should be recorded, handled and stored in
a way that allows its accurate reporting, interpretation and verification:
◦ ALCOACC ─ Attributable, Legible, Contemporaneous, Original, Accurate,
Complete, Consistent
◦ Maintenance of Trial and Site Master Files
◦ Archiving
◦ Validation

23. ACS_GCP_Version 1.0
Good Clinical Practice – The principles
of ICH GCP
 2.11: The confidentiality of records that could identify subjects should
be protected, respecting the privacy and confidentiality rules in
accordance with the applicable regulatory requirements:
◦ Patient ID Numbers
◦ Data protection / HIPAA
 2.12: Investigational products should be manufactured, handled and
stored in accordance with applicable good manufacturing practice
(GMP). They should be used in accordance with the approved
protocol:
◦ “Technical” Green Light ◦ QP release for European IMP

24. ACS_GCP_Version 1.0
Good Clinical Practice – The
principles of ICH GCP
 2.13: Systems with procedures that assure the quality of every aspect of
the trial should be implemented:
◦ Quality Control
◦ Monitoring
◦ Quality Assurance / Auditing

25. ACS_GCP_Version 1.0
Institutional Review Board (IRB) /
Independent Ethics Committee (IEB)
 The International Council on Harmonisation (ICH) defines an
institutional review board (IRB) is:
An Independent body (a review board or a committee, intituitional,
regional, national, or supranational), constituted of medical
professionals and non-medical members, whose responsibility it is to
ensure the protection of the rights, safety and wel-being of human
subjects involved in a trial and to provide public assurance of that
protection.
 IRBs (US) can also be called independent ethics committees (IECs;
EU).

26. ACS_GCP_Version 1.0
Institutional Review Board (IRB) /
Independent Ethics Committee (IEB)
 The IRB/IEC reviews the protocol for the study in the context of the
investigational site and the subject population of that site. They should
then provide an opinion as to whether the study is ethical for that
population and whether the site and Investigator are suitable to
conduct the study.
 The responsibilities of IRBs/IECs are set out in Chapter 3 of ICH GCP.
No changes were made to this chapter in the 2016 addendum.
Task: READ Chapter 3 of ICH GCP now.

27. ACS_GCP_Version 1.0
Investigator
 The investigator(s) should be qualified by education, training, and
experience to assume responsibility for the proper conduct of the trial,
should meet all the qualifications specified by the applicable regulatory
requirement(s), and should provide evidence of such qualifications
through up-to-date curriculum vitae and/or other relevant documentation
requested by the sponsor, the IRB/IEC, and/or the regulatory
authority(ies).
 The investigator should also be thoroughly familiar with the appropriate
use of the investigational product(s), as described in the protocol, in the
current Investigator’s Brochure, in the product information and in other
information sources provided by the sponsor.

28. ACS_GCP_Version 1.0
Investigator
 The responsibilities of Investigator(s) include clear oversight of study activities,
maintain patient welfare, ensure quality of data and be thoroughly familiar with
the appropriate use of the investigational product(s).
 The 2016 addendum emphasises the responsibility of the Investigator for
oversight of the trial at his/her site, the importance of appropriate delegation
and the need for adequate and accurate source documentation and trial records.
 The Investigator responsibilities are outlined in Chapter 4 of the ICH GCP
guidelines.
READ Chapter 4 of ICH GCP now. Complete the self assessment “ICH GCP
Chapter 4”.

29. ACS_GCP_Version 1.0
Sponsor
 The ICH GCP definition of the sponsor is “An individual, company,
institution, or organization which takes responsibility for the initiation,
management, and/or financing of a clinical trial.” In this regard, the
sponsor can be a pharmaceutical company, an Investigator, or an
Institution such as a hospital or a University or research charity.
 The sponsor is responsible for implementing and maintaining quality
assurance and quality control systems with written SOPs to ensure that
trials are conducted and data are generated, documented (recorded), and
reported in compliance with the protocol, GCP, and the applicable
regulatory requirement(s).

30. ACS_GCP_Version 1.0
Sponsor
 The responsibilities of the sponsor are set out in chapter 5 of ICH GCP and
include the responsibilities of the Monitor (also called Clinical Research
Associate/Scientist (CRA/CRS).
 The 2016 addendum includes new guidance on Quality Management of
clinical trials, particularly with reference to risk assessment and risk based
approaches to monitoring and management. It also includes the need for
a monitoring plan and the different benefits of centralised and on-site
monitoring. It also includes guidance on use of electronic systems,
including validation and ensuring data integrity.
 READ Chapter 5 of ICH GCP now. Complete the self assessment “ICH
GCP Chapter 5”.

31. ACS_GCP_Version 1.0
Protocol and Amendments
 ICH defines a clinical trial protocol as “a document that describes the
objective(s), design, methodology, statistical considerations, and
organization of a trial” and the Protocol Amendment as “a written
description of a change(s) to or formal clarification of a protocol.”
 Chapter 6 of ICH GCP provides guidance on the contents of the protocol
of a clinical trial, including information on the background/rationale and
instructions on how to conduct the study, the types of patients to be
included, the IMP and its use, study assessments to be conducted and
about the design and analysis of the study.
 READ Chapter 6 of ICH GCP now. Complete the self assessment “ICH
GCP Chapter 6”.

32. ACS_GCP_Version 1.0
Investigator Brochure
 The Investigator's Brochure (IB) is a compilation of the clinical and
nonclinical data on the investigational product(s) that are relevant to the
study of the product(s) in human subjects.
 Its purpose is to provide the investigators and others involved in the trial
with the information to facilitate their understanding of the rationale for,
and their compliance with, many key features of the protocol, such as the
dose, dose frequency/interval, methods of administration: and safety
monitoring procedures.

33. ACS_GCP_Version 1.0
Investigator Brochure
 The IB also provides insight to support the clinical management of the
study subjects during the course of the clinical trial.
 The information should be presented in a concise, simple, objective,
balanced, and non-promotional form that enables a clinician, or potential
investigator, to understand it and make his/her own unbiased risk-benefit
assessment of the appropriateness of the proposed trial.
 For this reason, a medically qualified person should generally participate
in the editing of an IB, but the contents of the IB should be approved by
the disciplines that generated the described data.

34. ACS_GCP_Version 1.0
Investigator Brochure
 This guideline delineates the minimum information that should be
included in an IB and provides suggestions for its layout. It is expected
that the type and extent of information available will vary with the stage of
development of the investigational product. If the investigational product
is marketed and its pharmacology is widely understood by medical
practitioners, an extensive IB may not be necessary.
 Where permitted by regulatory authorities, a basic product information
brochure, package leaflet, or labelling may be an appropriate alternative,
provided that it includes current, comprehensive, and detailed
information on all aspects of the investigational product that might be of
importance to the investigator.

35. ACS_GCP_Version 1.0
Investigator Brochure
 If a marketed product is being studied for a new use (i.e., a new
indication), an IB specific to that new use should be prepared.
 The IB should be reviewed at least annually and revised as necessary in
compliance with a sponsor's written procedures.
 More frequent revision may be appropriate depending on the stage of
development and the generation of relevant new information. However, in
accordance with Good Clinical Practice, relevant new information may be
so important that it should be communicated to the investigators, and
possibly to the Institutional Review Boards (IRBs)/Independent Ethics
Committees (IECs) and/or regulatory authorities before it is included in a
revised IB.

36. ACS_GCP_Version 1.0
Investigator Brochure
 Generally, the sponsor is responsible for ensuring that an up-to-date IB is
made available to the investigator(s) and the investigators are responsible
for providing the up-to-date IB to the responsible IRBs/IECs.
 The detail on Investigator brochure is outlined in Chapter 7 of the ICH
GCP guidelines.
READ Chapter 7 of ICH GCP now. Complete the self assessment “ICH GCP
Chapter 7”.

37. ACS_GCP_Version 1.0
Essential Documents –
for the conduct of a clinical trial
 Essential Documents are documents which individually and collectively permit
evaluation of the conduct of a trial and the quality of the data produced. These
documents serve to demonstrate the compliance of the investigator, sponsor and
monitor with the standards of Good Clinical Practice and with all applicable
regulatory requirements.
 Essential Documents also serve a number of other important purposes.
 Filing essential documents at the investigator/ institution and sponsor sites in a
timely manner can greatly assist in the successful management of a trial by the
investigator, sponsor and monitor. These documents are also the ones which are
usually audited by the sponsor's independent audit function and inspected by the
regulatory authority(ies) as part of the process to confirm the validity of the trial
conduct and the integrity of data collected.

38. ACS_GCP_Version 1.0
Essential Documents –
minimum list of essential documents
 The minimum list of essential documents which has been developed
follows. The various documents are grouped in three sections according to
the stage of the trial during which they will normally be generated:
1) before the clinical phase of the trial commences
2) during the clinical conduct of the trial, and
3) after completion or termination of the trial.
 A description is given of the purpose of each document, and whether it
should be filed in either the investigator/ institution or sponsor files, or
both. It is acceptable to combine some of the documents, provided the
individual elements are readily identifiable.

39. ACS_GCP_Version 1.0
Essential Documents –
Trial master files
 Trial master files should be established at the beginning of the trial, both at the
investigator/ institution's site and at the sponsor's office.
 A final close-out of a trial can only be done when the monitor has reviewed both
investigator/ institution and sponsor files and confirmed that all necessary
documents are in the appropriate files.
 Any or all of the documents addressed in this guideline may be subject to, and
should be available for, audit by the sponsor's auditor and inspection by the
regulatory authority(ies).
 The detail on Essential documents is outlined in Chapter 8 of the ICH GCP
guidelines.
READ Chapter 8 of ICH GCP now. Complete the self assessment “ICH GCP
Chapter 8”.

40. ACS_GCP_Version 1.0
Computer Systems – (21 CFR part 11)
electronic records; electronic signatures, 1997
 Computerized Systems used in Clinical Investigations, FDA, 2007
 Volume 10 of “The rules governing medicinal products in the European
Union”, chapter IV, annex III – computer systems, Eudralex 2008
 Good practices for computerised systems in regulated "gxp"
environments, PIC/S, 2007
 Requires: procedures and controls designed to ensure the authenticity,
integrity, and, when appropriate, the confidentiality of electronic records,
and to ensure that the signer cannot readily repudiate the signed record as
not genuine

41. ACS_GCP_Version 1.0
A computerised system is composed of:

42. ACS_GCP_Version 1.0
Computerised systems –
what are relevant standards
Statutory Instrument 2004/1031 (as amended)
– Regulation 31A (4) • The essential documents relating to a
clinical trial are those which…enable both the conduct of the
clinical trial and the quality of the data produced to be evaluated
– Schedule 1, Part 2 (9) • All clinical information shall be
recorded, handled and stored in a way that it can be accurately
reported, interpreted and verified, while the confidentiality of
records of the trial subjects remain protected.

43. ACS_GCP_Version 1.0
Computerised systems –
what are relevant standards?
EMA Reflection paper for laboratories that perform the analysis or
evaluation of clinical trial samples (2012), Section 6.16
– All computerised systems used for the capture, processing, manipulation,
reporting and storage of data should be developed, validated and
maintained in ways which ensure the validity, integrity and security of the
data
– Prior to use, all computerised systems should be subject to an appropriate
level of validation. The primary aim of any validation process will be to
demonstrate that the computerised system is fit for its intended purpose
and can produce reliable and reproducible data.

44. ACS_GCP_Version 1.0
Computerised systems –
what are relevant standards?
ICH E6 (R1) Guideline for Good Clinical Practice
– When using electronic trial data handling and/or
remote electronic trial data systems, the sponsor should:
– Ensure and document that the electronic data
processing system(s) conforms to the sponsors
established requirements for completeness, accuracy,
reliability, and consistent intended performance (i.e.
validation)

45. ACS_GCP_Version 1.0
Computerised systems -
Areas to audit
 User Requirement Specification (URS)
 Validation
 Change Control
 Security
 Back Up/ Recovery
 System Monitoring
 SOPs
 Training
 Data Archiving

46. ACS_GCP_Version 1.0
ICH E6(R2): Good Clinical Practice, 6/15
 In June, 2015 the ICH published this consensus draft for internal and
external consultation, according to national or regional procedures. The
comment period ended in January, 2016.
 The objective of this ICH GCP Guideline is to provide a unified standard
for the European Union (EU), Japan and the United States to facilitate the
mutual acceptance of clinical data by the regulatory authorities in these
jurisdictions.
 This addendum to the version of E6 approved in 1996 contains updated
standards regarding electronic records intended to increase clinical trial
quality and efficiency.

47. ACS_GCP_Version 1.0
ICH E6(R2)
software and computer system
 Section 1 (Glossary) definitions of audit trail, certified copy, validation of computerized
systems
 Section 4.9 (Records and Reports) requirements for audit trails for source data, source
documents, trial records, and CRF changes
 Section 5.0.2 (Risk Identification) inclusion of risks associated with computer systems
 Section 5.5 (Trial Management, Data Handling, and Record Keeping) detailed
requirements for system validation, user training, audit trails, security, backups,
blinding, upgrades and migrations, as well as SOPs for system validation, installation,
maintenance, security, change control, backup/recovery, contingency planning,
decommissioning, and data management
 Section 8 (Essential Documents) requirement for easy retrieval of essential documents
by both the sponsor and the investigator, whether paper or electronic

48. ACS_GCP_Version 1.0
Quiz
 Question 1
The sponsor should appoint individuals, who are independent of the clinical
trial/data collection system(s), to conduct audits.
True
False
 Question 2
An adverse event (AE) is any untoward medical occurrence in a patient or clinical
investigation subject administered a pharmaceutical product and that must have a
causal relationship with this treatment.
True
False

49. ACS_GCP_Version 1.0
Quiz
 Question 3
Monitor should be appointed by the ______.
1. Sponsor
2. Site
3. Subject
4. FDA
 Question 4
Upon request of the monitor, auditor, IRB/IEC, or regulatory authority, the
investigator/institution should make available for direct access all requested trial
related records only if a comprehensive list of such is provided at least 15 business
days prior to date of review/access.
True
False

50. ACS_GCP_Version 1.0
Quiz
 Question 5
The sponsor should verity that each ______ has consented, in writing, to direct access to his/her
original medical records for trial-related monitoring, audits, IRB/IEC review, and regulatory
inspection.
1. Doctor
2. Monitor
3. Site
4. Subject X
 Question 6
The investigator should promptly report to the IRB/IEC: [Select all that apply]
1. New information that may affect adversely the safety of the subjects or the conduct of the trial
2. All adverse drug reactions (ADRs) that are both serious and unexpected
3. All deviations from the protocol, regardless of severity
4. Changes increasing the risk to subjects and/or affecting significantly the conduct of the trial

51. ACS_GCP_Version 1.0
Quiz
 Question 7
What document includes an explanation of anticipated expenses, if any, to the subject for
participating in the trial?
1. Informed Consent
2. Statistical Analysis Plan (SAP)
3. Auditing Plan
4. Investigator's Brochure
 Question 8
The IRB/IEC should review a proposed clinical trial within a reasonable time and document its views in
writing, clearly identifying the trial, the documents reviewed,and the dates for the following:
(A) Approval/favorable opinion; (B) Modifications required prior to its approval/favorable opinion; (C)
Disapproval/negative opinion; and
(D) Termination/suspension of any prior approval/favorable opinion.
1. A, B, and C
2. A and C
3. A only
4. X All of the above

52. ACS_GCP_Version 1.0
Quiz
 Question 8
The purposes of trial monitoring are to verify that: (A) The rights and well-being of human
subjects are protected.(B) The reported trial data are accurate, complete, and verifiable from
source documents.(C) The conduct of the trial is in compliance with the currently approved
protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s).
1. A and C only
2. A only
3. X All of the above
4. None of the above
 Question 9
 A trial should be conducted in compliance with a protocol that has received prior institutional
review board (IRB)/independent ethics committee (IEC) approval/favorable opinion
 True
 False

53. ACS_GCP_Version 1.0
Quiz
 Question 10
The ______ should have sufficient time to properly conduct and complete the trial within the agreed trial
period.
1. Investigator
2. Monitor
3. Auditor
4. IRB
 Question 11
Which documents should the IRB/IEC obtain and review prior to approving a clinical trial? (select all that
apply)
1. Trial protocol(s)/amendments
2. Investigator's Brochure
3. Subject recruitment procedures
4. Monitoring confirmation letters
5. Written ICFs

54. ACS_GCP_Version 1.0
Quiz
 Question 12
 Who is responsible for the conduct of the clinical trial at a trial site?
1. Investigator
2. Sponsor
3. Clinical Research Coordinator
4. Monitor
 Question 13
Each individual involved in conducting a trial should be qualified by education, training, and
experience to perform his or her respective task(s).
1. X True
2. False

55. ACS_GCP_Version 1.0
Quiz
 Question 14
The IRB/IEC should consider the qualifications of the investigator and the
monitor for the purposed trial, as documented by a current curriculum vitae
and/or by any other relevant documentation the IRB/IEC requests.
1. True
2. X False
 Question 15
Clinical trials should be scientifically sound, and described in clear, detailed protocol.
 True
 False

56. ACS_GCP_Version 1.0
Quiz
Question 16
The sponsor is not obligated to submit to the regulatory authority(ies) all safety
updates and periodic reports, as required by applicable regulatory requirement(s)
 True
 X False

57. ACS_GCP_Version 1.0
Quiz
Thank you for completing our GCP course.
Please see our website for further courses or
contact us for face- face GCP delivery
www.acs.org.co.uk