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What are Essential What are Essential Documents?Documents?
Documents that permit evaluation of the conduct of a trial and the quality of the data
Auditable
Successful management of a clinical study
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List of Essential DocumentsList of Essential Documents
Before
During
After
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Before the Clinical StudyBefore the Clinical Study
Majority of the essential documents required by ICH/GCP need to be on file before the study starts
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During the Clinical StudyDuring the Clinical Study
Updates
Communication and reports
Adverse event reporting
Participant-related
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After the Clinical StudyAfter the Clinical Study
Final reportsClose-out monitoring reportReport by investigator to IRB/IECClinical study report, if required
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Document RetentionDocument Retention
CCP
Where?
How long?
Who is responsible?What if the investigator retires?
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Direct Access to DataDirect Access to Data
Sponsor including sponsor’s monitors and auditors
IRB/IEC
Regulatory authorities
September 30, 2004
Version Control Guidelines
Refer to the Version Control Flow Chart following the guidelines. 1. Document dates
a. The person primarily responsible for the document will ensure the date the document is created or revised is identified on the first page and, when possible, incorporated into the header or footer of the document and appears on every succeeding page. It will be possible for more than one version of the draft document to have the same date but unlikely for more than one version of a final document to have the same date.
2. Version numbers a. The person primarily responsible for the document will ensure the current version
number is identified on the first page and, when possible, incorporated into the header or footer of the document and appears on every succeeding page.
3. Draft documents version numbers a. The first draft of a document will be “0.1”. b. Subsequent drafts will have an increase of “0.1” in the version number, e.g.,
“0.2”, “0.3”…….“0.9”, “0.10”. 4. Final documents version numbers
a. The Protocol Champion will deem a protocol or other document (consent/assent form, case report form, manual of procedures) final after all reviewers have provided final comments and the comments have been addressed.
b. The first final version of a document will be “1.0”. c. Subsequent final documents will have an increase of “1.0” in the version number.
5. Final documents undergoing revisions a. Final documents undergoing revisions will be “X.1” for the first version of the
revisions. Subsequent revision versions will increase by “0.1”, e.g., the third draft of version “2.0” would be “2.3”. When the revised document is deemed final, the version will increase by “1.0” over the version being revised.
b. A list of changes from the previous document will be kept. The list will be cumulative and identify the changes from the immediately preceding version number. The list can be incorporated into the new document or kept in the project files.
Generally, the first final protocol version submitted to FDA is 1.0 if it is an IND study. If it is not an IND study, the first final protocol version to be implemented is 1.0
September 30, 2004
Version Control Flow Chart
Version Control
Document Date Date the document is created or revised is identified on the first page and, when possible, incorporated into the header or footer
of the document and appears on every succeeding page
First Draft
1st draft is version “0.1” – subsequent drafts will increase by “0.1”
First Final
First final version will be version “1.0”
Revisions to a Final Version
Final documents undergoing revisions will be “X.1” for the 1st draft subsequent drafts will increase by “0.1”
All changes will be documented
Subsequent Finals
Version number will increase by “1.0” above the version being revised
Version Number Current version number is identified on the first page and, when possible, incorporated into the header or footer of the document
and appears on every succeeding page
Essential Documents Exercise Work in groups and find answers to the following questions. Use the DMID Regulatory Document Guidelines to assist you.
1. According to the DMID Regulatory File Document Guidelines, the Study Personnel Signature/Responsibility List must include the signature and initials of study staff that are currently authorized to make entries and corrections to the CRFs, as well as laboratory personnel, study staff that obtain informed consent, and study staff that are responsible for maintaining IRB/IEC documents.
True / False (circle one)
2. Blank copies of all final versions of case report forms must be included in the Regulatory Binder.
True / False (circle one)
3. What is the purpose of the Regulatory Review History Log?
4. Every submission to the IRB/IEC must be maintained so that the submission
letter, copies of documents submitted, comments and questions received from the IRB/IEC, and the final IRB/IEC approval letter are kept together.
True / False (circle one)
5. Only the original IRB/IEC version of the protocol needs to be included in the Regulatory Binder; any subsequent IRB/IEC amendments do not need to be maintained in the Regulatory Binder.
True / False (circle one)
6. A final version of a protocol can have a version number 2.2 True / False (circle one) 8. Draft versions of protocols must be maintained in the Regulatory Binder True / False (circle one)
9. Copies of the blank original IRB/IEC approved consent form and subsequent IRB/IEC amendments to the consent forms need to be maintained in the Regulatory Binder
True / False (circle one)
10. How should annual renewals (also called continuing review approvals) be maintained in the Regulatory Binder?
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What is a Source Document?What is a Source Document?
Original
DocumentDataRecord
David Borasky/FHI
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Examples of Source DocumentsExamples of Source Documents
Hospital records
Clinic and office charts
Subject diaries
Pharmacy dispensing records
Recorded data from automated instruments
Subject files
X-rays
Case Report Forms *
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Why Have Source Documents?Why Have Source Documents?
Confirm participant existence
Verify study data
Starting point for an audit trail
Tita Oronoz/FHI
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CRFs as Source Documents CRFs as Source Documents
Clinical observations are recorded directly on CRFIdentified in protocolNot meant to replace ALL source documentationMaintain list of CRFs to be used at siteOriginal CRF must be signed and datedExamples:
PE CRF
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The Golden Rule of The Golden Rule of Clinical ResearchClinical Research
Data recorded on Case Report Forms (CRFs) must be consistent with Source DocumentsAny discrepancies should be explained
Source Documents = CRFs
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Corrections to Source Corrections to Source DocumentsDocuments
The original value must remain visibleThe new value addedDate change was madeInitials of person making the changeExplain, if necessary Unacceptable correction methods:
Correction fluidObliterationErasure
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Certified CopiesCertified Copies
Certified copy = originalCertified as being an exact copy by authorized person e.g. medical records specialistCertified copy must be dated and signed
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