CRP 104 Lecture 10

Question 1

principles of GCP (13)

Answer 1

-ethical principals (declaration of helsinki)
-favourable benefit to risk ratio
-subject’s rights over science
-adequate supporting data
-scientfically sound protocol
-REB review
-medical care by QI
-qualified personnel
-informed consent
-record-keeping
-confidentiality
-GMP
-QA and monitoring

Question 2

essential document definition

Answer 2

documents that individually and collectively permit evaluation of the conduct of CT and the quality of the data. Demonstrate compliance of investigator, sponsor, and monitor with GCP and regulations

Question 3

versioning

Answer 3

part of document controlm, should only use more recent version of a document, creates audit trail
-study site file contrains list of current documents with version numbers and dates

Question 4

study site file

Answer 4

or investigator site file akin to the trial master file kept with the sponsor.
-contains all study essential documents

Question 5

essential documents before the trial commences

Answer 5

-investigator’s brochure
-signed protocol and amendments show agreement of investigator and sponsor
-example CRFs “ “
-ICF
-any other written info given to subjects
-advertisements for recruitment (only investigator/site file)
-financial aspects (investigator, sponsor, manufacturer) for all sites
-insurance statement (for trial related injury)
-signed agreement between involved parties (CRP, sponsor, investigator, instituition)
-REB approval of protol, ICF, ads, written info, compensation, CRF
-composition of REB
-regulatory body authorization
-CV of investigators and sub investigators
-norma values/ranges for lab results and medical procedures
-certification of lab/facility to perform tests and procedures
-sample of label for IP (sponsor file only)
-instructions for IP hanidling and other materials
-shipment records for IP and materials
-certificate of analysis of IP shipped (identity, purity, strength)
-decoding procedures for blinded trials
-master randomization
-pretrial monitoring report of site
-trial initiation monitoring report(site trained on protocol)

Question 6

essential documents during the trial

Answer 6

-investigator brochure updates
-updates to ICF, CRF, protocol, written info for subjects, ads and the REB approval of changes
-CV of new investigators and subinvestigators
-updaes of medicl/lab/technical proedures/tests (certification, QC)
-tracking of IP and materials
-monitoring visit reports
-letters, meeting minutes, telephone calls of significant communications (Ae reporting)
-signed ICFs
-source docs
-signed, dated, complete CRFs
-AE reports to sponsor, REB and regulatory body
-interim/annual reports to REB
-subject screening log
-subject identification code list
-subject enrollment log
-IP accountability
-signature sheet
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Question 7

essential documents after trial

Answer 7

-IP accountability at sites
-IP destruction
-complete subject identification code list (if follow up needed), investigator file
-audit certificate in sponsor file
-final trial close out monitoring report (all closing procedures done, all documents filed in correct places)
-treatement allocation and decoding docs(return to sponsor), emergency decoding at site
-final report by investigator to REB and or regulatory body
-clinical study report (resuts and interpretation)

Question 8

patient files contain

Answer 8

signed and dates ICFs, source docs, significant communications

Question 9

archiving

Answer 9

all essential documents to assess the CT
-responsibility of investigator
-could use third party company
-must be kept for 25 years

Question 10

investigator’s brochure definiton

Answer 10

comprehensive document summarizing info on IP obtained during a drug trial. Preclinical and clinical data from previous studies.
provides investigator with info for management of study and subjects (helps determine doses, freqency of dose, administration methods, safety monitoring procedures)

Question 11

product information brochure

Answer 11

when IP is marketed ad widely understood by medical practitioners, do not need investigators brochure.

Question 12

IB updates

Answer 12

-sponsor provides updates to investigator
-investigator provides updates to REB

Question 13

sections of IB (10)

Answer 13

-title page (sponsor, IP identity, edition, date, of current and superceding version, confidentility statement)
-list of abbreviations
-table of contents
-summary (summary of critical info on IP specific to study)
-introduction (chemical name, generic and trade names, active ingredients, pharmacological class, rationale for research, IP properties)
-non-clinical studies (PK, PD, toxicity)
-clinical studies (humans)
-conclusion and guidance for investigator
-references