Checklist For GCP 2005 PDF

Checklist for GCP Compliance
Investigation (Medical Institution)

Japan Society of Quality Assurance, GCP Division
Kiyomi Hirayama1,*, Naohisa Fukuda2, Hitoshi Satoh3, Katsumi Itoh4, Kiyoshi Chiba5,
Yutaka Nakae6, Masayuki Takezawa7 and Kuniko Gotoh8
1
Quality Assurance Resources, Banyu Pharmaceutical Co. Ltd., AIG Kabutocho Building, 5-1, Nihom-bashi-
Kabutocho, Chuo-ku, Tokyo 103-0026, Japan
2
Quality Assurance, Pharmaceutical Development Division, Takeda Pharmaceutical Company Ltd., 4-1-1,
Doshomachi, Chuo-ku, Osaka 540-8645, Japan
3
Clinical Quality Control Group, Development & Regulatory, Abbott Japan Co. Ltd., 5-25-5 Sendagaya,
Shibuya-ku, Tokyo 151-8563, Japan
4
Regulatory Audit, Fujisawa Pharmaceutical Co. Ltd., 1-6, Kashima 2-chome, Yodogawa-ku, Osaka
532-8514, Japan
5
Quality & Regulatory Affairs Division, Quality Assurance Department, Kyowa Hakko Kogyo Co. Ltd.,
1-6-1, Ohtemachi, Chiyoda-ku, Tokyo 100-8185, Japan
6
Medical Quality Management Co. Ltd. 2-9-5-305, Ichikawa-Minami, Ichikawa 272-0033, Japan
7
Clinical Research Operations, Medical System Research Corp., Gracy Tenjinbashi Bldg. No2. 9F, 7-12-6
Tenjinbashi, Kita-ku, Osaka 531-0041, Japan
8
Quality Assurance, Sankyo Co. Ltd., 2-58, Hiromachi 1-chome, Shinagawa-ku, Tokyo 140-8710, Japan
Summary
This checklist is an English translation of the Good Clinical Practice (GCP) compliance
checklist prepared by the Japanese agency for on-site inspections of medical
institutions.y Please note that the checklist was translated by the authors and has not
received official review by any Japanese agency including the Organization for
Pharmaceutical Safety and Research (OPSR).
This checklist is an addendum to a previously published article on the evaluation of
overseas GCP inspections by the Japanese Regulatory Agency [1]. Copyright # 2005
John Wiley & Sons, Ltd.
Key Words: GCP inspection; GCP site audit; GCP checklist; Japanese Regulatory Agency;
MHLW
*Correspondence to: Kiyomi Hirayama, Quality Assurance Resources, Banyu Pharmaceutical Co. Ltd., AIG Kabutocho
Building, 5-1, Nihombashi-Kabutocho, Chuo-ku, Tokyo 103-0026, Japan. E-mail: kiyomi hirayama@merck.com
y
The Organization for Pharmaceutical Safety and Research (OPSR) in Japan has regularly conducted inspections at
sponsor and investigator sites/investigators. Overseas GCP inspections were conducted by Pharmaceuticals and
Medical Devices Evaluation Center (PMDEC) of National Institute of Health Sciences of Ministry of Health, Labor and
Welfare (MHLW) up until March 2004. Inspectors of OPSR and PMDEC used this checklist in inspections. However,
these procedures and checklist may change in the future as OPSR and PMDEC were integrated into the
Pharmaceuticals and Medical Devices Agency (PMDA) as a special public corporation of MHLW, on 1 April 2004.
Copyright r 2005 John Wiley & Sons, Ltd. Qual Assur J 2005; 9, 120–139.
DOI: 10.1002/qaj.333
Checklist 121
Checklist
Name of the medical institution:

Product for investigation (generic name):
Sponsor’s name (company name):
Documents to be investigated:
Date of GCP investigation by PMDA investigators:
PMDA investigators’ names:
I. Overview of the Medical Institution
1. Requirements for medical institutions [Article 35: Retroactive application]
Numbers in the parentheses indicate the situation in the department/specialty in charge of the trial.
[] Suitable
Institution Department/specialty:
Number of beds:
Number of inpatients: ( )
Number of outpatients: ( )
Personnel Number of doctors: ( )

Number of dentists:
Number of pharmacists:
Number of nurses:
Number of lab technicians:
Number of X-ray technicians:
* Has the facilities and personnel necessary for conducting adequate clinical
observation and laboratory testing.
* Is able to execute necessary measures when an emergency arises with subjects.
* Has established an Institutional Review Board (IRB) (excluding those cases
corresponding to the exception rule).
* Has secured the necessary number of staff, such as investigator, sub-investigators,
pharmacists, nurses and other personnel.
[] Other:
2. Status of the conduct of clinical trials
Numbers in the parentheses indicate the situation in the department/specialty in charge of the trial.
During the conduct of the trial:

(e.g. 1998) I: ( ) II: ( ) III: ( )
(e.g. 1999) I: ( ) II: ( ) III: ( )
(e.g. 2000) I: ( ) II: ( ) III: ( )
122 K. Hirayama et al.
Status of recent trial conduct:

(e.g. 2001) I: ( ) II: ( ) III: ( )
(e.g. 2002) I: ( ) II: ( ) III: ( )
(e.g. 2003) I: ( ) II: ( ) III: ( )
3. Control/management system for the trial work

(1) Preparation of Standard Operating Procedures (SOPs) for clinical trial activities
[Article 36, Paragraph 1]
[] Suitable
Title:
Preparation date:
Revision date: Revision date: Revision date:
Areas covered: [ ] Business procedures

[ ] Clinical trial secretariat
[ ] Control of investigational drug
[ ] Retention of records
[ ] Other:
[] Other:
(2) Procedures necessary to permit the proper and smooth conduct of clinical trials
(Designation of sub-investigators and trial collaborators, means dissemination of information in the
medical institution: enforcement notification)
[] Suitable
[] Other:
(3) Appointment of clinical trial secretariat [Article 38]

[] Suitable
Organization:
Date of establishment:
Number of CRC members:
CRC members present:
In case of Site Management Organization (SMO) contract:

Name of SMO:
Scope of SMO’s business:
[] Other:
(4) Collaboration in reviews by monitoring, auditing and the IRB

[Article 37, Paragraph 1, Paragraph 2]
[] Suitable
[] Other:
Checklist 123
II. Institutional Review Board (IRB)
1. Establishment of the IRB
(1) During the conduct of the trial – name of IRB:
(2) Present – name of IRB:
Basis of establishment
[] Establishment within the medical institution [Article 27]

[] Establishment outside the medical institution [Provision of Article 27]
[] Establishment of the IRB in collaboration with the heads of other medical institutions
[Provision of Article 27]
[] Establishment by non-profit organization [Provision of Article 27]
[] Establishment by an academic society composed of qualified medical personnel
[Provision of Article 27]
[] Establishment by the head of another medical institution [Provision of Article 27]
2. Composition of the IRB, etc. [Article 28, Paragraph 1]
[] Suitable
[] Capable of fully reviewing the clinical trial from ethical and scientific viewpoints
[] Comprised of five or more members
[] Having members (at least one person) other than those with expert knowledge in
medicine, dentistry, pharmacy, other areas of medical care, or clinical trials
(enforcement notification)
[] Having members (at least one person) not related to the medical institution
(enforcement notification)
[] Head of the medical institution unable to be a member of this medical institution’s
IRB (enforcement notification)
Preparation of board membership list [Article 28, Paragraph 2]
[] Suitable (membership list available)

[] Other:
[] Other:
3. Utilization of other IRB
Obtain SOPs and a list of members for the IRB utilized, except for IRB established by the medical
institution [Article 30, Paragraphs 2 and 3]
[] Not applicable
[] Suitable
Name of other IRB:
[] SOPs for the IRB concerned

[] Board membership list
[] Minutes (obtained as needed)
[] Other:
4. Preparation of SOPs, etc.
(1) Preparation of SOPs documenting the following items and the conduct of tasks in accordance
with these SOPs [Article 28, Paragraph 2]
[] Suitable
Preparation date:
Revision date: Revision date: Revision date:
Regulation items
[] Method of selecting a chair

[] Requirements for a board meeting (handling of attendees who are not
medical specialists or are not related to the medical institution: enforcement
notification)
[] Matters concerning conduct of the meeting (includes the handling of minor
changes: enforcement notification)
[] Persons who have close relationships with the sponsor, the head of the
medical institution, investigator/sub-investigators, or trial collaborators
shall not participate in discussions or vote on a clinical trial reviewed by
the IRB [Article 29, Paragraph 1]
[] Board members who do not participate in the discussions shall not
participate in the voting [Article 29, Paragraph 2]
[] Timing for judging the appropriateness of continuing a clinical trial when
the clinical trial period exceeds one year [Article 31, Paragraph 1]
[] Procedures for documentation of IRB meetings (including IRB membership
list and meeting agenda: enforcement notification)
[] Procedures for record retention
[] Necessary additional items
[] Other:
(2) Appointment of an individual to handle the administrative tasks of the IRB

[] Suitable
Person in charge: Name:

Title
[] Other:
Checklist 125
5. Operations involving the IRB
(1) Requests for the opinion of the IRB on the appropriateness of conducting a clinical trial
[Article 30, Paragraph 1: Retrospective application]
[] Suitable
Request date: Date of request for opinion:
[] Other:
(2) Review and documented opinion on the appropriateness of the clinical trial
[] Suitable
Review date: Time required: minutes/item

Document distribution time:
Conclusion: [] Approval
[] Modification required prior to its approval
[] Rejection
Contents:
Review documents
[ ] Protocol, sample of case report form, written information

[ ] Investigator’s brochure
[ ] Documents citing names of prospective investigator/sub-investigator(s)
[ ] Documents indicating anticipated payments to the medical institution
[ ] Documents on compensation to subjects for impairment of health
[ ] Materials for subject recruitment
[ ] Documents concerning the quality of the investigational drug, its efficacy
and safety, or other information important for the proper conduct of the
clinical trial
[] Current curriculum vitae of prospective investigator/sub-investigator(s)
[] Other documents the IRB deems necessary
[] Other:
(3) Notification in writing of the opinion of the IRB [Article 32, Paragraph 3]
[] Suitable
Head of medical institution ! Sponsor Notification date:
Head of medical institution ! Investigator Notification date:
[] Other:
(4) Review and opinion, notification of any major amendments to the protocol
[] Not applicable
[] Suitable

Document distribution time:
Conclusion, etc.:
[] Other:
(5) Review of the appropriateness of continuing the clinical trial when the clinical trial
period exceeds one year (at least once a year) and notification in writing of the opinion
[Article 31, Paragraph 1, Article 32, Paragraphs 2 and 3]
(a) Report of a summary of the status of clinical trial [Article 48, Paragraph 1]
[] Not applicable
[] Suitable
[] Other:
(b) Review, etc.
[] Not applicable
[] Suitable

Trial period:
[] Modification required prior to approval
[] Withdrawal of existing approval
Contents:
Checklist 127

[] Other:
(6) Review of the appropriateness of continuing the clinical trial when information is
obtained about serious adverse reactions, and notification in writing of the opinion
[Article 31, Paragraph 2, Article 32, Paragraphs 2 and 3]
(a) Report in writing of any unexpected and serious adverse reactions
[] Not applicable
[] Suitable
Sponsor ! Head of medical institution Receipt date:

Head of medical institution ! IRB Notification date:
Details of Adverse Reactions:
[] Other:
(b) Review, etc.
[] Not applicable
[] Suitable
[] Modification required prior to its approval
[] Withdrawal of existing approval
Contents:

[] Other:
6. Retention of records
Retention of the following records (until the manufacturing approval date for the investigational drug
or three years from the date of the termination or completion of the clinical trial) [Article 34]
[] Suitable
* SOPs for the IRB.

* Board membership list.
Documents submitted for IRB review
* Protocol.
* Investigator’s brochure.
* Sample of case report form.
* Written subject information/consent form.
* Documents citing names of prospective investigator/sub-investigator(s).
* Documents indicating anticipated payments to the medical institution.
* Documents on compensation to subjects for impairment of health.
* Materials concerning subject recruitment procedures.
* Documents concerning information important for the proper conduct of the clinical
trial.
* Current curriculum vitae of prospective investigator/sub-investigator(s).
* Notification to the IRB (adverse reaction reports, report of termination or completion of
the clinical trial).
* Meeting minutes of the IRB (attendees, review results, opinions and agenda points,
etc.).
[] Other:
III. Investigator (requirements, tasks, etc.)
1. Requirements for investigator [Article 42]
[] Suitable
Investigator Name:
Title:
* Fully qualified by education and training.

* Adequate clinical experience.
* Knowledgeable in trial protocol, investigator’s brochure, and proper use of the
investigational drug.
* Sufficient time available to conduct the clinical trial.
[] Other:
2. Preparation of a list of tasks to be assigned to any sub-investigators or trial collaborators

[] Not applicable
[] Suitable
[] Approval of the head of the medical institution (enforcement notification)
[] Other:
Checklist 129
3. Supply of necessary information for sub-investigators or trial collaborators

[] Not applicable
[] Suitable
[] Explanation of the details of the clinical trial (protocol, investigator’s brochure etc.)
[] Supply of information (information about adverse reactions, etc. provided by the
sponsor)
[] Other:
IV. Control of the Clinical Trial

1. Adverse reactions, etc.
(1) Report in writing of any ‘unexpected and serious adverse reactions’ [II.-5.-6)-a]
(2) Report in writing of any ‘serious adverse events’
[] Not applicable
[] Suitable
Investigator ! Head of medical institution Notification date:

Investigator ! Sponsor Notification date:
Details of Adverse Reactions:
[] Other:
(3) Report in writing of cancellation or suspension of the clinical trial (specify the reason)
[] Not applicable
[] Suitable
a) Sponsor ! Head of medical institution Notification date:

Investigator ! Subjects Notification date:
[] Provision of appropriate medical treatment to subjects
b) Investigator ! Head of medical institution Receipt date:

[] Other:
(4) Report in writing of ‘completion of the clinical trial’ (summary of trial results to be
attached)
[] Suitable
Investigator ! Head of medical institution Receipt date:

[] Other:
2. Deviations from protocol to eliminate any immediate hazards to subjects
(a-1) When an investigator has deviated from the protocol in order to eliminate an
immediate hazard to subjects or for other unavoidable medical reasons, the investigator
shall document all such deviations, and submit documentation describing those
deviations and the reasons thereof to the sponsor and the head of the medical institution
[Article 46].
[] Not applicable
[] Suitable
Details of deviation, etc.:
Investigator ! Head of medical institution Submission date:

Investigator ! IRB Submission date:
Investigator ! Sponsor Submission date:
[] Other:
(a-2) Review, etc.
[] Not applicable
[] Suitable
Review date:
[] Other
Contents:
IRB ! Head of medical institution Notification date:

Head of medical institution ! Investigator Approval date:
Agreement by sponsor ! Investigator Notification date:
[] Other:
Checklist 131
(b) Investigator/sub-investigators must keep a record of every deviation from the protocol
regardless of the reason, and should prepare and submit records explaining the reasons thereof
to the sponsor [Implementation Notification Article 46]
[] Not applicable
[] Suitable
Details of deviation, etc.:
Investigator ! Sponsor Submission date:
[] Other:
3. Control of investigational drug
(1) Appointment of an investigational drug storage manager [Article 39]
[] Suitable
Investigational drug storage manager, etc. Name:

Title (Type):
[] Other:
(2) Provision of SOPs (prepared by the sponsor) for investigational drug storage management
[] Suitable
Date of provision of SOPs:
[] Other:
(3) Appropriate control of investigational drug (according to relevant SOPs) [Article 39,
Paragraph 2]
[] Suitable
Investigational drug storage site:

Control of in/out from storage site:
[] Records of receipt, stock, and use of the investigational drug (implementa-

tion notification)
Prohibition of receipt before finalization of the contract for the clinical trial
[Article 11]
[] Record of disposal or return of unused investigational drug (implementation
notification)
[] Preparation of table for investigational drug accountability (use conditions
based on the protocol, record conditions of the trial progress)
[] Segregation of investigational drug and other drugs
[] Other:
4. Retention of records
(1) Appointment of person responsible for record retention [Article 41, Paragraph 1]
[] Suitable
Record retention responsible Name:

Title:
[] Other:
(2) Retention of records (until the manufacturing approval date for the investigational
drug or three years after the date of termination/completion of the trial) [Article 41,
Paragraph 2]
[] Suitable
Records storage site:

Control of in/out from storage site:
Documents to be retained:
[] Source documents (medical records, records of drug administration, records/

data, X-rays, etc.: enforcement notification)
[ ] Contract
[ ] Informed consent form and written subject information
[ ] Protocol
[ ] Documents obtained from the IRB
[ ] Records of investigational drug accountability
[] Other:
V. Communication with the trial subjects
1. Selection of prospective subjects, responsibilities to subjects
(1) Requirements for prospective subjects [Article 44: Retrospective application]
[] Suitable
* Subject’s health condition, symptoms, age, ability to give consent, etc. shall be
carefully considered in accordance with the objectives of the clinical trial, from
both ethical and scientific perspectives.
Checklist 133
* No subject incapable of giving consent shall be selected unless his/her enrollment

as a subject in the clinical trial is unavoidable.
* In selecting any subject who might suffer undue disadvantage if he/she does
not consent to participate in the trial, careful steps shall be taken so that the
subject can voluntarily give consent (medical, dental, pharmacy, and nursing
students; hospital personnel; pharmaceutical industry employees, etc.).
[] Other:
(2) Explanation and, if necessary, confirmation, of proper use of the investigational drug to subject
[] Not applicable
[] Suitable
[] Proper explanation and instruction given to the subject

[] Confirmation that each subject is properly following the instructions
explained
[] Other:
(3) In the event any subject is receiving treatment by other physicians, notification to the relevant
physicians of the subject’s participation in the clinical trial with the subject’s agreement
[] Not applicable
[] Suitable
Case No. Notification Date Method of Notification, etc.

No.
No.
No.
[] Other:
(4) Necessary measures/precautions to provide proper medical care for the subjects in case of
experiencing adverse events [Article 45, Paragraph 3]
[] Suitable
[] Other:
(5) In the case of an adverse event occurring in a subject that requires treatment, notification to the
subject of the fact [Article 45, Paragraph 4]
[] Not applicable
[] Suitable
[] Other:
2. Explanation
(1) Issuance of written information covering the items listed below [Article 51,
Paragraph 1]
[] Suitable
[ ] Fact that the clinical trial involves research

[ ] Objectives of the clinical trial
[ ] Name, title and address of the investigator to contact
[ ] Trial method (including those aspects of the trial that are experimental,
subject inclusion/exclusion criteria, and the probability for random assign-
ment to each treatment: enforcement notification)
[ ] Anticipated benefits and disadvantages
[ ] Details concerning alternative therapeutic measures
[ ] Duration of participation in the clinical trial
[ ] Fact that the subjects can withdraw from the clinical trial at any time
[ ] Fact that the subject’s refusal or withdrawal from participation in the clinical
trial does not cause any disadvantage to him/her
[] Fact that the confidentiality of the subject is fully respected
[] Office of medical institution to contact in the event of impairment to
health
[] Fact that necessary treatment is available to the subject in the event of
impairment to health
[] Details concerning compensation for impairment to health
[] Fact that monitors, auditors, IRB, and regulatory authorities are allowed
access to the source documents while respecting the subject’s confi-
dentiality
[] Other necessary details (approximate number of subjects involved in the
trial, circumstances and reasons for termination of subject’s participation,
anticipated payments, etc.: enforcement notification)
[] Other:
(2) Details whose inclusion in written information is forbidden [Article 51, Paragraph 2]
[] Suitable
[] Fact that the prospective subjects appear to waive their rights, etc.
[] Fact that any of the responsibilities of the sponsor, medical
institution, investigator, or sub-investigator(s) have been dispensed with or
reduced
[] Other:
Checklist 135
(3) Preparation of written information using language and expressions that are as non-technical as
practicable and understandable to the subject [Article 51, Paragraph 3]
[] Suitable
[] Other:
(4) Method of informing the subjects
[] Suitable
[] Proper explanation to each prospective subject using written information [Article 50,
Paragraph 1]
[] Other:
(5) Sufficient time for questions and answers with subjects or their legally acceptable
representatives [Article 50, Paragraph 5]
[] Suitable
Time required: approximately minutes/person
[] Other:
3. Explanation in special situations
In life-saving clinical trials in emergency situations, conditions for enrolling subjects without
obtaining their consent or the consent of their legally acceptable representatives [Article 55,
Paragraph 1]
[] Not applicable
[] Suitable
Case No.:
[] Prospective subject is in medical emergency and obviously experiencing a life-

threatening risk
[] Conventional treatments cannot be expected to be sufficiently effective
[] There is a good possibility of avoiding life-threatening risk(s) in the prospective
subject through use of the investigational drug
[] Anticipated disadvantages to the subject in the clinical trial should be minimal
[] Person serving as the prospective subject’s legally acceptable representative cannot be
reached immediately
[] Other:
4. Communication of information that might affect the subjects’ willingness to continue

participation in the clinical trial
(1) Supply of relevant information to the subjects, recording to the documentation, confirmation of
subjects’ willingness to continue participation in the clinical trial [Article 54, Paragraph 1]
[] Not applicable
[] Suitable
[] Is information supplied promptly? (evidence of information)

[] Was sufficient opportunity given for questions and answers?
[] Is there any coercion of the consent?
[] Other:
(2) Prompt revision of written information as needed [Article 54, Paragraph 2]
[] Not applicable
[] Suitable
Information acquisition date: (IRB: )
Revision date:
[] Other:
(3) In case the written information is revised, report to the head of the medical institution,
obtaining of subjects’ consent (or their legally acceptable representatives’ consent) to their
continued participation in the clinical trial [Article 54, Paragraph 3]
[] Not applicable
[] Suitable
Reporting date:
Obtaining of subjects’ consent:
[] Other:
IV. Case reports, etc.
1. Record of consent, etc.
(1) Written consent by prospective subjects [Article 50, Paragraph 1]

Signed informed consent form, etc. [Article 52, Paragraph 1]
Exclusion of any consent given under duress [Article 52, Paragraph 2]
Issuance of informed consent form (copy) to subject [Article 53]
Checklist 137
[] Suitable
[] Investigator/sub-investigator(s) giving explanation, and prospective subjects

(or their legally acceptable representatives) personally date, seal and/or sign
the informed consent form
[] Impossibility of coercing the consent
[] Issuance of copy of above informed consent form to subjects (or their legally
acceptable representatives)
[] Other:
(2) Consent by prospective subject’s legally acceptable representative when it is difficult to obtain
consent by the prospective subject [Article 50, Paragraph 2]
[] Not applicable
[] Suitable
[] Other:
(3) Documentation of consent provided by the prospective subject’s legally acceptable

representative and the relationship of the subject’s representative to the subject
[] Not applicable
[] Suitable
[] Other:
(4) Presence of a witness when the prospective subject is incapable of reading the written
information [Article 52, Paragraph 3]
[] Not applicable
[] Suitable
[] Witness shall be neither investigator/sub-investigators nor trial collaborators

[] Other:
(5) In life-saving clinical trials under emergency conditions, the subject or prospective subject’s
legally acceptable representative should be informed about the trial as soon as possible and
consent to continue should be obtained [Article 55, Paragraph 2]
[] Not applicable
[] Suitable
[] Progress and results should be reported to the IRB (enforcement notification)
[] Other:
2. Case report forms (case records)
(1) Accurate preparation of case report forms (case records) in accordance with the protocol and
affixing of seal and/or signature of the investigator [Article 47, Paragraph 1]
[] Consistency with the protocol (Article 46: [IV.2.])
[] Consistency with the source documents (comparison and verification) [Article 47,
Paragraph 1]
(When there is any contradiction, a record must be prepared explaining the reason
[implementation notification])
(2) Changes or corrections made to case report forms

Dated and either sealed or signed (in case of important changes or corrections, the reason must
be provided in writing) [Article 47, Paragraph 2]
[] Suitable
[] Other:
(3) Investigator must check case report forms prepared by sub-investigators, verify the contents,
and seal and/or sign them [Article 47, Paragraph 3]
[] Suitable
[] Other:
Contract for the clinical trial
1. Consistency of the contents of request, IRB, and contract
[] Suitable
[] Other:
2. Contents of the contract [Article 13]
[] Suitable
[] Date the contract was finalized
Checklist 139
[ ] Name and address of the prospective sponsor

[ ] Name and address of the CRO and the scope of assigned duties
[ ] Name and location of the medical institution
[ ] Name and title of the person in charge of the contract
[ ] Names and titles of investigator and sub-investigator(s) (all members when two or
more sub-investigators)
[] Duration of the clinical trial
[] Targeted number of subjects
[] Statement that the medical institutions shall conduct the clinical trial in compliance
with the protocol
[] Statement that the sponsor can cancel the contract if the medical institution is found
to have violated GCP, the protocol or contract, thereby compromising the proper
conduct of the clinical trial
[] Details concerning compensation for impairment of health in subjects
[] Other details necessary to ensure that the clinical trial is properly and smoothly
conducted
[] Details concerning control of investigational drugs
[] Details concerning retention of records (including data)
[] Details concerning notifications to be made by the sponsor and persons engaged in the
medical institutions
[] Details concerning trial fees/payment
[] Details concerning maintenance of the confidentiality of the subject (prohibition
against publication of confidential information related to the subject [Article 80-2,
Paragraph 10 of the Law])
[] Statement that the medical institution shall provide the sponsor with access to the
records (source documents, contract, informed consent forms and written informa-
tion, protocol, documents obtained from the IRB, records of investigational drug
control and other trial-related records)
[] Other:
Reference
[1] Hirayama K, Fukuda N, Satoh H, et al. Overseas GCP inspections by the Japanese regulatory agency: a systematic
review of 13 cases (1998–2003). Qual Assur J 2004; 9(1): 14–21.

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Checklist for GCP Compliance

Investigation (Medical Institution)

Name of the medical institution:

I. Overview of the Medical Institution

1. Requirements for medical institutions [Article 35: Retroactive application]

Personnel Number of doctors: ( )

2. Status of the conduct of clinical trials

During the conduct of the trial:

Status of recent trial conduct:

3. Control/management system for the trial work

Areas covered: [ ] Business procedures

(3) Appointment of clinical trial secretariat [Article 38]

In case of Site Management Organization (SMO) contract:

(4) Collaboration in reviews by monitoring, auditing and the IRB

II. Institutional Review Board (IRB)

1. Establishment of the IRB

(1) During the conduct of the trial – name of IRB:

(2) Present – name of IRB:

[] Establishment within the medical institution [Article 27]

2. Composition of the IRB, etc. [Article 28, Paragraph 1]

Preparation of board membership list [Article 28, Paragraph 2]

[] Suitable (membership list available)

3. Utilization of other IRB

Name of other IRB:

[] SOPs for the IRB concerned

4. Preparation of SOPs, etc.

[] Method of selecting a chair

(2) Appointment of an individual to handle the administrative tasks of the IRB

Person in charge: Name:

5. Operations involving the IRB

Request date: Date of request for opinion:

Review date: Time required: minutes/item

[ ] Protocol, sample of case report form, written information

Head of medical institution ! Sponsor Notification date:

Head of medical institution ! Investigator Notification date:

Review date: Time required: minutes/item

Head of medical institution ! Investigator Notification date:

Head of medical institution ! Investigator Notification date:

(b) Review, etc.

Review date: Time required: minutes/item

Head of medical institution ! Sponsor Notification date:

(a) Report in writing of any unexpected and serious adverse reactions

Sponsor ! Head of medical institution Receipt date:

Details of Adverse Reactions:

(b) Review, etc.

Review date: Time required: minutes/item

Head of medical institution ! Sponsor Notification date:

* SOPs for the IRB.

Documents submitted for IRB review

III. Investigator (requirements, tasks, etc.)

1. Requirements for investigator [Article 42]

* Fully qualified by education and training.

2. Preparation of a list of tasks to be assigned to any sub-investigators or trial collaborators

[] Approval of the head of the medical institution (enforcement notification)

3. Supply of necessary information for sub-investigators or trial collaborators

IV. Control of the Clinical Trial

Investigator ! Head of medical institution Notification date:

Details of Adverse Reactions:

a) Sponsor ! Head of medical institution Notification date:

[] Provision of appropriate medical treatment to subjects

b) Investigator ! Head of medical institution Receipt date:

Investigator ! Head of medical institution Receipt date:

2. Deviations from protocol to eliminate any immediate hazards to subjects