Post on 07-Apr-2018
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How are Documents Filed?
Before the clinical trialstarts
During theconduct ofThe clinicaltrial
Aftercompletion of the
trial
According to the stage of the trial
Sponsor/CRO
According to the file type
Investigator
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Trial master file (TMF)
TMF should be filed at the beginning of the trial.
It should be present at both the sponsors site and the trial site
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Essential documents
Chapter 8 in ICH-GCP provides a list of essential documents
required in a trial
The additional documents required are the 1572 form and
financial disclosure form
Sponsor defined documents;
Training manuals
Laboratory normal values
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ICH-GCP chapter 8
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GCP Essential Documents forClinical Trials
Investigators Brochure
Signed protocol and amendments and sample CRF Information given to trial subjects
Informed Consent including translations
All written information Advertisement for recruitment
Financial documents / agreements
Insurance statement (if required)
Signed agreements between all involved parties: Investigator
Institution
Sponsor CRO
Regulatory authorities (where required)
Keep all versions of these documents during the trial
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Continued
Dated & approved IRB documents
Dated & approved Protocol and amendments
Dated & approved Case Report Forms (when applicable)
Informed consent forms
All other written information provided to subjects
Advertisements for subject recruitment
Subject Compensation (if any)
Other documents approved by IRB
IRB review board and ethics committee composition Regulatory authorization (where required)
Curriculum Vitae of investigators and sub investigators
- Updated, signed and dated every 2 years
Normal value ranges for laboratory tests
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Continued.
Lab certifications and accreditations - if required
Certifications
QA/QC assessment
Other validation as required
Shipping and receiving records for investigational products
Decoding procedures for blinded trials
Master randomization list
Trial initiation monitoring report (if applicable)
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Continued
Investigators brochure updates
Revisions to original:
Protocol & amendments
Informed consent form
Case Report Forms (CRFs)
Materials provided to subjects
Advertisements for subject recruitment
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Continued
Regulatory authorizations and approvals
Curriculum Vitae for new investigators or sub-investigators
Signed, dated and updated every 2 years
Updates to lab values/certifications
Investigational product and trial related materials shipment and
receipt
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Continued..
Correspondence / Communications
Letters, meeting notes, notes of telephone calls and emails
Signed Informed Consent Forms
Source Documents
Documents in which data collected for a clinical trial is first
recorded, these data are usually later entered in the casereport form
Examples of source documents include: medical records, labreports, subject diaries, x-rays, ECG printouts
Signed, dated and completed case report forms (CRFs)
The Case Report Form is the tool used to collect data from
the study. Copies of CRF corrections
Source: ibpa.org
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Continued
Adverse Event reports
Unexpected and Serious Adverse Event Reports
Safety information notifications
Interim or Annual reports to IRB and authorities
Subject Screening Log
Subject Identification code list
Subject enrollment log
Source: ibpa.org
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Continued
Drug / device accountability log
Site signature / delegation of duties log
Record of retained body fluids and tissues
Completed drug / device accountability log
Documentation of return or destruction of investigational product
Completed subject identification code list
Final report by investigator
Clinical study report
Source: ibpa.org
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Records
Regulatory minimum:
The records of all essential documents for drugs have to bemaintained for 2 years from the date of application to market(whether approved or not)
The records for medical devices have to be maintained for 2 yearsfrom study completion, termination or when records to supportapproval are no longer needed
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During this planning stage the following documents should be
generated and should be on file before the trial formally starts
Before the start of the trial
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Before the clinical phase of the trial commences
Title of document Located in files ofinvestigator
Located in files ofsponsor
Investigators
BrochureX X
Signed protocol and
amendments
X X
Case Report Form(CRF)
X X
Informed ConsentForm
X X
Financial aspect ofthe trial
X X
Insurance statement X
(if required)
X
Source: Roche
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Before the clinical phase of the trial commences
Title of document Located in files ofinvestigator
Located in files ofsponsor
Signed agreement
between involvedparties
X X
Dated, documentedapproval of IRB/IEC
X X
IRB/IEC composition X X
Investigator and sub-investigators curriculum
vitae
X X
Laboratory normalrange and certification
X X
Source: Roche
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Before the clinical phase of the trial commences
Title of document Located in files ofinvestigator
Located in files ofsponsor
Instruction for handlingof investigationalproduct
X X
Investigational productlabel
X
(if required)
X
Decoding proceduresfor blinded trials X X
Randomization list X X
Pre-trial and initiationmonitoring report
Site keeps minutes ofinitiation visit
X
Source: Roche
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During the conduct of the trial
In addition to having on file the above documents, the following
documents should be kept on file as evidence that all new
relevant information is documented as it becomes available
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During the clinical conduct of the trial
Title of document Located in files ofinvestigator
Located in files ofsponsor
Investigators Brochure(update)
X X
Any revision toprotocol, ICF, CRF etc.and IRB/IEC approval
X X
Update investigators
curriculum vitaeX X
Update laboratorynormal range and
certification
X X
Investigational productlabel for new batch
X
(if required)
X
Source: Roche
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During the clinical conduct of the trial
Title of document Located in files ofinvestigator Located in files ofsponsor
Monitoring report X
Relevant
communication
X X
Signed informedconsent forms
X
Source documents X
Signed, dated and
completed CRF
X
(copy)
X
(original)
Documentation ofCRF correction
X(copy)
X(original)
Signature sheet X X
Source: Roche
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During the clinical conduct of the trial
Title of document Located in files ofinvestigator
Located in files ofsponsor
Notification of SAEs
and related reports
X X
Interim or annualreports
X X
Subject screening log X X(if required)
Subject enrolment log X
Subject identificationcode list
X
Investigationalproducts accountability
X
Source: Roche
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After completion of the trial
After completion or termination of the trial, all of the documents
identified in the above tables should be in the file together with
the following
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After completion or termination of the trial
Title of document Located in files ofinvestigator
Located in files ofsponsor
Investigational
products accountability
X
(original)
X
(copy)
Documentation ofInvestigationalproducts destruction
X X
Completed subject
identification code list
X
Audit certificate X
Final trial close outmonitoring report
X
Source: Roche
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After completion or termination of the trial
Title of document Located in files ofinvestigator
Located in files ofsponsor
Treatment allocation
and decodingdocumentation
X
Final report to IRB/EC X X
Clinical study report X X
Source: Roche