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.?

Answer:

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)

Principal investigator

Sub-investigators

Clinical coordinators

Appropriate staff

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

Investigator’s Brochure

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

Source documents

Protocol deviation log

Outcome events log

Notes to file / notes to binder

Screening log

Subject enrollment log

IND safety letters