|
Title
of Document
|
Purpose
|
Located
in Files of
|
Investigator
/ Institution
|
Sponsor
|
8.2.1 |
INVESTIGATOR'S
BROCHURE |
To
document that relevant and current scientific information about
the investigational product has been provided to the investigator |
X
|
X
|
8.2.2 |
SIGNED
PROTOCOL AND AMENDMENTS, IF ANY, AND SAMPLE CASE REPORT FORM (CRF) |
To document investigator and sponsor agreement to the protocol/
amendment(s) and CRF |
X
|
X
|
8.2.3 |
INFORMATION GIVEN TO TRIAL SUBJECT |
. |
.
|
.
|
|
- INFORMED CONSENT FORM (including translations) |
To
document the informed consent |
X
|
X
|
|
- ANY OTHER WRITTEN INFORMATION |
To
document that subjects will be given appropriate written information
(content and wording) to support their ability to give fully informed
consent |
X
|
X
|
|
- ADVERTISEMENT FOR SUBJECT RECRUITMENT (if used) |
To
document that recruitment measures are appropriate and not coercive |
X
|
.
|
8.2.4
|
FINANCIAL
ASPECTS OF THE TRIAL |
To
document the financial agreement between the investigator/ institution
and the sponsor for the trial |
X
|
X
|
8.2.5
|
INSURANCE
STATEMENT (where required) |
To
document that compensation to subject(s) for trial-related injury
will be available |
X
|
X
|
8.2.6
|
SIGNED
AGREEMENT BETWEEN INVOLVED PARTIES, e.g.: |
To
document agreements |
.
|
.
|
|
- investigator/ institution and sponsor |
. |
X
|
X
|
|
- investigator/ institution and CRO
|
. |
X
|
X
(where required)
|
|
- sponsor and CRO
|
. |
X
|
X
|
|
-
investigator/ institution and authority(ies) |
. |
X
|
X
|
8.2.7
|
DATED,
DOCUMENTED APPROVAL/ FAVOURABLE OPINION OF INSTITUTIONAL REVIEW
BOARD (IRB) / INDEPENDENT ETHICS COMMITTEE (IEC) OF THE FOLLOWING:
- protocol and any amendments
- CRF (if applicable)
- informed consent form(s)
- any other written information to be provided to the subject(s)
- advertisement for subject recruitment (if used)
- subject compensation (if any)
- any other documents given approval/ favourable opinion
|
To
document that the trial has been subject to IRB/ IEC review and
given approval/ favourable opinion. To identify the version number
and date of the document(s). |
X
|
X
|
8.2.8
|
INSTITUTIONAL
REVIEW BOARD/ INDEPENDENT ETHICS COMMITTEE COMPOSITION |
To
document that the IRB/ IEC is constituted in agreement with GCP
(where required) |
X
|
X
|
8.2.9
|
REGULATORY
AUTHORITY(IES) AUTHORISATION/ APPROVAL/ NOTIFICATION OF PROTOCOL
(where required) |
To
document appropriate authorisation/ approval/ notification by the
regulatory authority(ies) has been obtained prior to initiation
of (where the trial in compliance with the applicable regulatory
requirement(s) |
X
(where required)
|
X
(where required)
|
8.2.10
|
CURRICULUM
VITAE AND/ OR OTHER RELEVANT DOCUMENTS EVIDENCING QUALIFICATIONS
OF INVESTIGATOR(S) AND SUB-INVESTIGATOR(S) |
To
document qualifications and eligibility to conduct trial and/ or
provide medical supervision of subjects |
X
|
X
|
8.2.11
|
NORMAL
VALUE(S)/ RANGE(S) FOR MEDICAL/ LABORATORY/ TECHNICAL PROCEDURE(S)
AND/ OR TEST(S) INCLUDED IN THE PROTOCOL |
To
document normal values and/ or ranges of the tests results |
X
|
X
|
8.2.12
|
MEDICAL/
LABORATORY/ TECHNICAL PROCEDURES/ TESTS
- certification or
- accreditation or
- established quality control and/ or external quality assessment
or
- other validation
|
To
document competence of facility to perform required test(s), and
support reliability of results |
X
(where required)
|
X
|
8.2.13
|
SAMPLE
OF LABEL(S) ATTACHED TO INVESTIGATIONAL PRODUCT CONTAINER(S) |
To
document compliance with applicable labelling regulations and appropriateness
of instructions provided to the subjects |
.
|
X
|
8.2.14
|
INSTRUCTIONS
FOR HANDLING OF INVESTIGATIONAL PRODUCT(S) AND TRIAL-RELATED MATERIALS
(if not included in protocol or Investigator's related materials
Brochure) |
To
document instructions needed to ensure proper storage, packaging,
dispensing and disposition of investigational products and trial |
X
|
X
|
8.2.15
|
SHIPPING
RECORDS FOR INVESTIGATIONAL PRODUCT(S) AND TRIAL-RELATED MATERIALS
|
To
document shipment dates, batch numbers and method of shipment of
investigational product(s) and trial-related materials. Allows tracking
of product batch, review of shipping conditions, and accountability |
X
|
X
|
8.2.16 |
CERTIFICATE(S)
OF ANALYSIS OF INVESTIGATIONAL PRODUCT(S) SHIPPED |
To
document identity, purity, and strength of investigational product(s)
to be used in the trial |
.
|
X
|
8.2.17
|
DECODING
PROCEDURES FOR BLINDED TRIALS |
To
document how, in case of an emergency, identity of blinded investigational
product can be revealed without breaking the blind for the remaining
subjects' treatment |
X
(third party if applicable)
|
X
|
8.2.18
|
MASTER
RANDOMISATION LIST |
To
document method for randomisation of trial population |
X
|
X
(third party if applicable)
|
8.2.19
|
PRE-TRIAL
MONITORING REPORT |
To
document that the site is suitable for the trial (may be combined
with 8.2.20) |
.
|
X
|
8.2.20
|
TRIAL
INITIATION MONITORING REPORT |
To
document that trial procedures were reviewed with the investigator
and the investigator's trial staff ( may be combined with 8.2.19) |
X
|
X
|
|
Title
of Document
|
Purpose
|
Located
in Files of
|
Investigator/
Institution
|
Sponsor
|
8.3.1
|
INVESTIGATOR'S
BROCHURE UPDATES |
To
document that investigator is informed in a timely manner of relevant
information as it becomes available |
X
|
X
|
8.3.2
|
ANY
REVISION TO:
- protocol/ amendment(s) and CRF
- informed consent form
- any other written information provided to subjects
- advertisement for subject recruitment (if used)
|
To
document revisions of these trial related documents that take effect
during trial |
X
|
X
|
8.3.3
|
DATED,
DOCUMENTED APPROVAL/ FAVOURABLE OPINION OF INSTITUTIONAL REVIEW
BOARD (IRB)/ INDEPENDENT ETHICS COMMITTEE (IEC) OF THE FOLLOWING:
- protocol amendment(s)
- revision(s) of
- informed consent form
- any other written information to be provided to the subject
- advertisement for subject recruitment (if used)
- any other documents given approval/ favourable opinion
- continuing review of trial (where required)
|
To
document that the amendment(s) and/ or revision(s) have been subject
to IRB/ IEC review and were given approval/ favourable opinion.
To identify the version number and date of the document(s) |
X
|
X
|
8.3.4
|
REGULATORY
AUTHORITY(IES) AUTHORISATIONS/ APPROVALS/ NOTIFICATIONS WHERE REQUIRED
FOR:
- protocol amendment(s) and other documents
|
To
document compliance with applicable regulatory requirements |
X
|
X
(where required)
|
8.3.5
|
CURRICULUM
VITAE FOR NEW INVESTIGATOR(S) AND/ OR SUB- INVESTIGATOR(S)
|
(see
8.2.10) |
X
|
X
|
8.3.6
|
UPDATES
TO NORMAL VALUE(S)/ RANGE(S) FOR MEDICAL/ LABORATORY/ TECHNICAL
PROCEDURE(S)/ TEST(S) INCLUDED IN THE PROTOCOL |
To
document normal values and ranges that are revised during the trial
(see 8.2.11) |
X
|
X
|
8.3.7
|
UPDATES
OF MEDICAL/ LABORATORY/ TECHNICAL PROCEDURES/ TESTS
- certification or
- accreditation or
- established quality control and/ or external quality assessment
or
- other validation (where required)
|
To
document that tests remain adequate throughout the trial period
(see 8.2.12) |
X
|
(where
required) X
|
8.3.8
|
DOCUMENTATION
OF INVESTIGATIONAL PRODUCT(S) AND TRIAL-RELATED MATERIALS SHIPMENT
|
(see
8.2.15) |
X
|
X
|
8.3.9
|
CERTIFICATE(S)
OF ANALYSIS FOR NEW BATCHES OF INVESTIGATIONAL PRODUCTS |
(see
8.2.16) |
.
|
X
|
8.3.10
|
MONITORING
VISIT REPORTS |
To
document site visits by, and findings of, the monitor |
.
|
X
|
8.3.11
|
RELEVANT
COMMUNICATIONS OTHER THAN SITE VISITS
- letters
- meeting notes
- notes of telephone calls
|
To
document any agreements or significant discussions regarding trial
administration, protocol violations, trial conduct, adverse event
(AE) reporting |
X
|
X
|
8.3.12
|
SIGNED
INFORMED CONSENT FORMS |
To
document that consent is obtained in X accordance with GCP and protocol
and dated prior to participation of each subject in trial. Also
to document direct access permission (see 8.2.3) |
X
|
.
|
8.3.13
|
SOURCE
DOCUMENTS |
To
document the existence of the subject and X substantiate integrity
of trial data collected. To include original documents related to
the trial, to medical treatment, and history of subject |
X
|
.
|
8.3.14
|
SIGNED,
DATED AND COMPLETED CASE REPORT FORMS (CRF) |
To
document that the investigator or authorised member of the investigator's
staff confirms the observations recorded |
X
(copy)
|
X
(original)
|
8.3.15
|
DOCUMENTATION
OF CRF CORRECTIONS |
To
document all changes/ additions or corrections made to CRF after
initial data were recorded |
X
(copy)
|
X
(original)
|
8.3.16
|
NOTIFICATION
BY ORIGINATING INVESTIGATOR TO SPONSOR OF SERIOUS ADVERSE EVENTS
AND RELATED REPORTS |
Notification
by originating investigator to sponsor of serious adverse events
and related reports in accordance with 4.11 |
X
|
X
|
8.3.17
|
NOTIFICATION
BY SPONSOR AND/ OR INVESTIGATOR, WHERE APPLICABLE, TO REGULATORY
AUTHORITY(IES) AND IRB(S)/ IEC(S) OF UNEXPECTED SERIOUS ADVERSE
DRUG REACTIONS AND OF OTHER SAFETY INFORMATION |
Notification
by sponsor and/ or investigator, where applicable, to regulatory
authorities and IRB(s)/ IEC(s) of unexpected serious adverse drug
reactions in accordance with 5.17 and 4.11.1 and of other safety
information in accordance with 5.16.2 and 4.11.2 |
X
(where required)
|
X
|
8.3.18
|
NOTIFICATION
BY SPONSOR TO INVESTIGATORS OF SAFETY INFORMATION |
Notification
by sponsor to investigators of safety information in accordance
with 5.16.2 |
X
|
X
|
8.3.19
|
INTERIM
OR ANNUAL REPORTS TO IRB/ IEC AND AUTHORITY(IES) |
Interim
or annual reports provided to IRB/ IEC in accordance with 4.10 and
to authority(ies) in accordance with 5.17.3 |
X
|
X
(where required)
|
8.3.20
|
SUBJECT
SCREENING LOG |
To
document identification of subjects who entered pre-trial screening
|
X
|
X
(where required)
|
8.3.21
|
SUBJECT
IDENTIFICATION CODE LIST |
To
document that investigator/ institution keepsa confidential list
of names of all subjects allocated to trial numbers on enrolling
in the trial. Allows investigator/ institution to reveal identity
of any subject |
X
|
.
|
8.3.22
|
SUBJECT
ENROLLMENT LOG |
To
document chronological enrollment of subjects by trial number |
X
|
.
|
8.3.23
|
INVESTIGATIONAL
PRODUCTS ACCOUNTABILITY AT THE SITE |
To
document that investigational product(s) have been used according
to the protocol |
X
|
X
|
8.3.24
|
SIGNATURE
SHEET |
To
document signatures and initials of all persons authorised to make
entries and/ or corrections on CRFs |
X
|
X
|
8.3.25
|
RECORD
OF RETAINED BODY FLUIDS/ TISSUE SAMPLES (IF ANY) |
To
document location and identification of retained samples if assays
need to be repeated |
X
|
X
|
|
Title
of Document
|
Purpose
|
Located
in Files of
|
Investigator
/ Institution
|
Sponsor
|
8.4.1
|
INVESTIGATIONAL
PRODUCT(S) ACCOUNTABILITY AT SITE |
To
document that the investigational product(s) have been used according
to the protocol. To document the final accounting of investigational
product(s) received at the site, dispensed to subjects, returned
by the subjects, and returned to sponsor |
X
|
X
|
8.4.2
|
DOCUMENTATION
OF INVESTIGATIONAL PRODUCT DESTRUCTION |
To
document destruction of unused investigational products by sponsor
or at site |
X
(if destroyed at site)
|
X
|
8.4.3
|
COMPLETED
SUBJECT IDENTIFICATION CODE LIST |
To
permit identification of all subjects enrolled in the trial in case
follow-up is required. List should be kept in a confidential manner
and for agreed upon time |
X
|
.
|
8.4.4
|
AUDIT
CERTIFICATE (if available) |
To
document that audit was performed |
.
|
.
|
8.4.5
|
FINAL
TRIAL CLOSE-OUT MONITORING REPORT |
To
document that all activities required for trial close-out are completed,
and copies of essential documents are held in the appropriate files |
X
|
.
|
8.4.6
|
TREATMENT
ALLOCATION AND DECODING DOCUMENTATION |
Returned
to sponsor to document any decoding that may have occurred |
X
|
.
|
8.4.7
|
FINAL
REPORT BY INVESTIGATOR TO IRB/ IEC WHERE REQUIRED, AND WHERE APPLICABLE,
TO THE REGULATORY AUTHORITY(IES) |
To
document completion of the trial |
X
|
.
|
8.4.8
|
CLINICAL
STUDY REPORT |
To
document results and interpretation of trial |
X
|
X
|