Question15: Please create a checklist for a pre-investigation visit for a phase II clinical trial on X-micine: a new anti-viral compound that reduces the death rate from S. A. R. S.?
Prestudy Activities Checklist
Following is the checklist for a pre- investigation for a Phase II clinical trial on X- micine(a new anti-viral compound that reduces the death rate from S. A. R. S.)
Site Evaluation Visit by Sponsor/Sponsor Rep
Review protocol with principal investigator
Tour research site, hospital, laboratory, pharmacy as appropriate
Organize Site Initiation Visit (document training)
Clinical research pharmacist
Compiling Prestudy Documents
Site Survey Form
Confidentiality Agreement: Must be signed by the principal investigator before study protocol can be sent.
FDA Form 1572: Must be signed by principal investigator. Summarizes the FDA requirements for participating in a clinical study. All sub-investigators must be listed.
Curriculum Vitae (CV): Required of the principal investigator and all sub-investigators. In addition CVs of the clinical research coordinator and lab director are required when appropriate
Financial Disclosures: Required of the principal investigator and all sub-investigators
Laboratory Certification: A copy of local laboratory licenses and the normal laboratory values for the laboratory to be used must be kept on file.
Signed Protocol Agreement: Must be signed by the principal investigator.
Study Contract/Budget: Between the sponsor, principal investigator, and institutions where research will be conducted.
IRB Informed Consent Form Approval
IRB protocol approval letter
IRB informed consent form approval letter
IRB patient information / advertising approval letter
Approved HIPPA Form
IRB Membership List
Test Article Inventory / Accountability Record
Test Article Storage Area Temperature Log
Case Report Forms
Adverse / Serious Adverse Event Forms
Additional documents will be needed as study progresses. Examples include:
Amendments to study protocol
Executed informed consents
Diagnostic test results
Test article inventory / shipping invoices / packing slips
Protocol deviation log
Outcome events log
Notes to file / notes to binder
Subject enrollment log
IND safety letters
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