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ACRP - MDP Subspeciality > ICH-E6A - Location of Essential Documents > Flashcards

ICH-E6A - Location of Essential Documents Flashcards

Name the location and purpose of said essential documents

1
Q

Before the Clinical Phase of the Trial Commences:

INVESTIGATOR’S BROCHURE

A

Both

To document that relevant and current scientific information about the investigational product has been provided to the investigator

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2
Q

Before the Clinical Phase of the Trial Commences:

SIGNED PROTOCOL AND AMENDMENTS, IF ANY, AND SAMPLE CASE REPORT FORM (CRF)

A

Both

To document investigator and sponsor agreement to the protocol/amendment(s) and CRF

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3
Q

Before the Clinical Phase of the Trial Commences:

INFORMATION GIVEN TO TRIAL SUBJECT
- INFORMED CONSENT FORM
including all applicable translations

A

Both

To document the informed consent

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4
Q

Before the Clinical Phase of the Trial Commences:

  • ANY OTHER WRITTEN INFORMATION
A

Both

To document that subjects will be given appropriate written information (content and wording) to support their ability to give fully informed consent

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5
Q

Before the Clinical Phase of the Trial Commences:

  • ADVERTISEMENT FOR SUBJECT RECRUITMENT (if used)
A

Investigator/Institution

To document that recruitment measures are appropriate and not coercive

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6
Q

Before the Clinical Phase of the Trial Commences:

FINANCIAL ASPECTS OF THE TRIAL

A

Both

To document the financial agreement between the investigator/institution and the sponsor for the trial

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7
Q

Before the Clinical Phase of the Trial Commences

INSURANCE STATEMENT
where required

A

Both

To document that compensation to subject(s) for trial-related injury will be available

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8
Q

Before the Clinical Phase of the Trial Commences:

SIGNED AGREEMENT BETWEEN INVOLVED PARTIES, e.g.:

  1. investigator/institution and sponsor
  2. investigator/institution and CRO
  3. sponsor and CRO
  4. investigator/institution and authority(ies) (where required)
A
  1. Both
  2. investigator and where required at sponsor
  3. Sponsor
  4. Both

To document agreements

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9
Q

Before the Clinical Phase of the Trial Commences:

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

A

Both to all

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)

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10
Q

Before the Clinical Phase of the Trial Commences:

INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE COMPOSITION

A

investigator and where required at sponsor

To document that the IRB/IEC is constituted in agreement with GCP

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11
Q

Before the Clinical Phase of the Trial Commences:

REGULATORY AUTHORITY(IES
AUTHORISATION/APPROVAL/
NOTIFICATION OF PROTOCOL
where required)

A

Where required for both

To document appropriate authorisation/approval/notification by the regulatory authority(ies) has been obtained prior to initiation of the trial in compliance with the applicable regulatory requirement(s)

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12
Q

Before the Clinical Phase of the Trial Commences:

CURRICULUM VITAE AND/OR OTHER RELEVANT DOCUMENTS EVIDENCING QUALIFICATIONS OF INVESTIGATOR(S) AND SUB-INVESTIGATOR(S)

A

Both

To document qualifications and eligibility to conduct trial and/or provide medical supervision of subjects

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13
Q

Before the Clinical Phase of the Trial Commences:

NORMAL VALUE(S)/RANGE(S) FOR MEDICAL/ LABORATORY/TECHNICAL PROCEDURE(S) AND/OR TEST(S) INCLUDED IN THE PROTOCOL

A

Both

To document normal values and/or ranges of the tests

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14
Q

Before the Clinical Phase of the Trial Commences:

MEDICAL/LABORATORY/TECHNICAL PROCEDURES /TESTS

  • certification or
  • accreditation or
  • established quality control and/or external quality assessment or
  • other validation (where required)
A

Sponsor and where required at investigator

To document competence of facility to perform required test(s), and support reliability of results

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15
Q

Before the Clinical Phase of the Trial Commences:

SAMPLE OF LABEL(S) ATTACHED TO INVESTIGATIONAL PRODUCT CONTAINER(S)

A

Sponsor

To document compliance with applicable labelling regulations and appropriateness of instructions provided to the subjects

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16
Q

Before the Clinical Phase of the Trial Commences:

INSTRUCTIONS FOR HANDLING OF INVESTIGATIONAL PRODUCT(S) AND TRIAL-RELATED MATERIALS
(if not included in protocol or Investigator’s Brochure)

A

Both

To document instructions needed to ensure proper storage, packaging, dispensing and disposition of investigational products and trial-related materials

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17
Q

Before the Clinical Phase of the Trial Commences:

SHIPPING RECORDS FOR INVESTIGATIONAL PRODUCT(S) AND TRIAL-RELATED MATERIALS

A

Both

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

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18
Q

Before the Clinical Phase of the Trial Commences:

CERTIFICATE(S) OF ANALYSIS OF INVESTIGATIONAL PRODUCT(S) SHIPPED

A

Sponsor

To document identity, purity, and strength of investigational product(s) to be used in the trial

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19
Q

Before the Clinical Phase of the Trial Commences:

DECODING PROCEDURES FOR BLINDED TRIALS

A

Investigator and Sponsor (third party if applicable)

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

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20
Q

Before the Clinical Phase of the Trial Commences:

MASTER RANDOMISATION LIST

A

Sponsor (Third Party if applicable)

To document method for randomisation of trial population

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21
Q

Before the Clinical Phase of the Trial Commences:

PRE-TRIAL MONITORING REPORT

A

Sponsor

To document that the site is suitable for the trial (may be combined with 8.2.20)

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22
Q

Before the Clinical Phase of the Trial Commences:

TRIAL INITIATION MONITORING REPORT

A

Both

To document that trial procedures were reviewed with the investigator and the investigator’s trial staff ( may be combined with 8.2.19)

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23
Q

During the Clinical Conduct of the Trial:

INVESTIGATOR’S BROCHURE UPDATES

A

Both

To document that investigator is informed in a timely manner of relevant information as it becomes available

24
Q

During the Clinical Conduct of the Trial:

ANY REVISION TO:
- protocol/amendment(s) and CRF
- informed consent form
- any other written information provided to subjects
- advertisement for subject recruitment
(if used)
A

Both

To document revisions of these trial related documents that take effect during trial

25
Q

During the Clinical Conduct of the Trial:

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)

A

Both

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).

26
Q

During the Clinical Conduct of the Trial:

REGULATORY AUTHORITY(IES) AUTHORISATIONS/APPROVALS/NOTIFICATIONS WHERE REQUIRED FOR:
- protocol amendment(s) and other documents
A

Sponsor and where applicable for Investigator

To document compliance with applicable regulatory requirements

27
Q

During the Clinical Conduct of the Trial:

CURRICULUM VITAE FOR NEW INVESTIGATOR(S) AND/OR SUB-INVESTIGATOR(S)

A

Both

28
Q

During the Clinical Conduct of the Trial:

UPDATES TO NORMAL VALUE(S)/RANGE(S) FOR MEDICAL/ LABORATORY/ TECHNICAL PROCEDURE(S)/TEST(S) INCLUDED IN THE PROTOCOL

A

Both

To document normal values and ranges that are revised during the trial (see 8.2.11)

29
Q

During the Clinical Conduct of the Trial:

UPDATES OF MEDICAL/LABORATORY/ TECHNICAL PROCEDURES/TESTS

  • certification or
  • accreditation or
  • established quality control and/or external quality assessment or
  • other validation (where required)
A

Sponsor and where applicable for Investigator

To document that tests remain adequate throughout the trial period (see 8.2.12)

30
Q

During the Clinical Conduct of the Trial:

DOCUMENTATION OF INVESTIGATIONAL PRODUCT(S) AND TRIAL-RELATED MATERIALS SHIPMENT

A

Both

31
Q

During the Clinical Conduct of the Trial:

CERTIFICATE(S) OF ANALYSIS FOR NEW BATCHES OF INVESTIGATIONAL PRODUCTS

A

Sponsor

32
Q

During the Clinical Conduct of the Trial:

MONITORING VISIT REPORTS

A

Sponsor

To document site visits by, and findings of, the monitor

33
Q

During the Clinical Conduct of the Trial:

RELEVANT COMMUNICATIONS OTHER THAN SITE VISITS

  • letters
  • meeting notes
  • notes of telephone calls
A

Both

To document any agreements or significant discussions regarding trial administration, protocol violations, trial conduct, adverse event (AE) reporting

34
Q

During the Clinical Conduct of the Trial:

SIGNED INFORMED CONSENT FORMS

A

Investigator

To document that consent is obtained in 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)

35
Q

During the Clinical Conduct of the Trial:

SOURCE DOCUMENTS

A

Investigator

To document the existence of the subject and substantiate integrity of trial data collected. To include original documents related to the trial, to medical treatment, and history of subject

36
Q

During the Clinical Conduct of the Trial:

SIGNED, DATED AND COMPLETED
CASE REPORT FORMS (CRF)

A

To document that the investigator or authorised member of the investigator’s staff confirms the observations recorded

37
Q

During the Clinical Conduct of the Trial:

DOCUMENTATION OF CRF CORRECTIONS

A

Copy at Investigator, Original at Sponsor

To document that the investigator or authorised member of the investigator’s staff confirms the observations recorded

38
Q

During the Clinical Conduct of the Trial:

NOTIFICATION BY ORIGINATING INVESTIGATOR TO SPONSOR OF SERIOUS ADVERSE EVENTS AND RELATED REPORTS

A

Copy at Investigator, Original at Sponsor

To document all changes/additions or corrections made to CRF after initial data were recorded

39
Q

During the Clinical Conduct of the Trial:

NOTIFICATION BY ORIGINATING INVESTIGATOR TO SPONSOR OF SERIOUS ADVERSE EVENTS AND RELATED REPORTS

A

Both

Notification by originating investigator to sponsor of serious adverse events and related reports in accordance with 4.11

40
Q

During the Clinical Conduct of the Trial:

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

A

Sponsor and where required by investigator

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

41
Q

During the Clinical Conduct of the Trial:

NOTIFICATION BY SPONSOR TO INVESTIGATORS OF SAFETY INFORMATION

A

Both

Notification by sponsor to investigators of safety information in accordance with 5.16.2

42
Q

During the Clinical Conduct of the Trial:

INTERIM OR ANNUAL REPORTS TO IRB/IEC AND AUTHORITY(IES)

A

Investigator and where required by sponsor

Interim or annual reports provided to IRB/IEC in accordance with 4.10 and to authority(ies) in accordance with 5.17.3

43
Q

During the Clinical Conduct of the Trial:

SUBJECT SCREENING LOG

A

Investigator and where required by sponsor

To document identification of subjects who entered pre-trial screening

44
Q

During the Clinical Conduct of the Trial:

SUBJECT IDENTIFICATION CODE LIST

A

Investigator

To document that investigator/institution keeps a 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

45
Q

During the Clinical Conduct of the Trial:

SUBJECT ENROLMENT LOG

A

Investigator

To document chronological enrolment of subjects by trial number

46
Q

During the Clinical Conduct of the Trial:

INVESTIGATIONAL PRODUCTS ACCOUNTABILITY AT THE SITE

A

Both

To document that investigational product(s) have been used according to the protocol

47
Q

During the Clinical Conduct of the Trial:

SIGNATURE SHEET

A

Both

To document signatures and initials of all persons authorised to make entries and/or corrections on CRFs

48
Q

During the Clinical Conduct of the Trial:

RECORD OF RETAINED BODY FLUIDS/ TISSUE SAMPLES (IF ANY)

A

Both

To document location and identification of retained samples if assays need to be repeated

49
Q

After Completion or Termination of the Trial:

INVESTIGATIONAL PRODUCT(S) ACCOUNTABILITY AT SITE

A

Both

To document that the investigational product(s) have been used according to the protocol. To documents the final accounting of investigational product(s) received at the site, dispensed to subjects, returned by the subjects, and returned to sponsor

50
Q

After Completion or Termination of the Trial:

DOCUMENTATION OF INVESTIGATIONAL PRODUCT DESTRUCTION

A

Sponsor and Investigator (if destroyed at site)

To document destruction of unused investigational products by sponsor or at site

51
Q

After Completion or Termination of the Trial:

COMPLETED SUBJECT IDENTIFICATION CODE LIST

A

Investigator

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

52
Q

After Completion or Termination of the Trial:

AUDIT CERTIFICATE (if available)

A

Sponsor

To document that audit was performed

53
Q

After Completion or Termination of the Trial:

FINAL TRIAL CLOSE-OUT MONITORING REPORT

A

Sponsor

To document that all activities required for trial close-out are completed, and copies of essential documents are held in the appropriate files

54
Q

After Completion or Termination of the Trial:

TREATMENT ALLOCATION AND
DECODING DOCUMENTATION

A

Sponsor

Returned to sponsor to document any decoding that may have occurred

55
Q

After Completion or Termination of the Trial:

FINAL REPORT BY INVESTIGATOR TO IRB/IEC WHERE REQUIRED, AND WHERE APPLICABLE, TO THE REGULATORY AUTHORITY(IES)

A

Investigator

To document completion of the trial

56
Q

After Completion or Termination of the Trial:

CLINICAL STUDY REPORT

A

Sponsor and Investigator where applicable

To document results and interpretation of trial

ACRP - MDP Subspeciality (13 decks)

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