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Guidance for Organization of Human Research Regulatory Records
Guidance for maintaining study records
is
available on
this VBRI website. The guidance is on the Procedures page. [See:
Guidance for
Organization of Human Research Regulatory Records]
Not all the
sections are applicable to all studies. Sample forms and
explanations are provided. The forms are intended to serve as
examples that may be adapted for your use. The contents include:
ESSENTIAL DOCUMENTS
Protocol & Amendments
Operations Manual
- Approved Case Report Forms
IRB Approved Consent Forms / Information Provided to Subjects
Subject Log / Clinic Lists in CPRS
IRB Submissions / Notifications / Approvals
Serious Adverse Events / Safety Reports
Notes-to-File
Investigator Agreements (with Sponsor, Institution, FDA, etc.)
Study Site Personnel (Signatures, Qualifications, Training)
Site-Sponsor Correspondence
- Conference call minutes (section tab provided)
- Newsletters (section tab provided)
Investigator Brochure (DIR) / VA Form 10-9012
Investigational Products (Accountability, Handling, Pharmacy)
Laboratory
Subject Files
Visitor Log
(Site Visitor Log would be a more accurate term for this
form)
More
information:
Forms and Tools may be obtained from the SMART Website
https://vaww.csp.research.med.va.gov/smart.cfm
Posted Dec
5th,2008 |