Documents

Debbie Farkas
Mind Map by Debbie Farkas, updated more than 1 year ago
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Documentos de estudio

Resource summary

SPONSOR
1 Original CDA
1.1 Copy of CDA
1.2 Original Feasibility Form
1.2.1 Original Site Qualification Visit Form
1.2.1.1 Original Selection Visit Form
1.2.1.1.1 A Contract with Original Signatures
1.2.1.1.1.1 A Contract with Original Signatures
1.2.1.1.1.2 Copy of IB and P.I. Acknowledgment Form
1.2.1.1.1.2.1 Original IB Acknowledgment form
1.2.1.1.1.2.2 Protocol and Protocol Signature Page Copy
1.2.1.1.1.2.2.1 Original P.I. Protocol Signature Page
1.2.1.1.1.2.2.2 Original CV's with Signature in Sponsor's Format
1.2.1.1.1.2.2.2.1 Copy of GCP Certificates and Licensures,
1.2.1.1.1.2.2.2.1.1 Copy of GCP Certificates and Licensures
1.2.1.1.1.2.2.2.1.1.1 Copy of GCP and Licensures
1.2.1.1.1.2.2.2.1.2 Copy of Submission letters with IRB/MOH Approval
1.2.1.1.1.2.2.2.1.2.1 Original Submission letters with Approvals
1.2.1.1.1.2.2.2.1.2.1.1 Copy of submission letters with Original IRB/MOH Stamp of Approval
1.2.1.1.1.2.2.2.1.2.2 Wet ink Financial Disclosure Forms (if applicable)
1.2.1.1.1.2.2.2.1.2.2.1 Copy of Financial Disclosure Forms (if applicable)
1.2.1.1.1.2.2.2.1.2.2.2 Original 1572 FDA Form (if applicable)
1.2.1.1.1.2.2.2.1.2.2.2.1 Copy of 1572 FDA Form (if applicable)
1.2.1.1.1.2.2.2.1.2.2.2.1.1 Copy of IRB Roster
1.2.1.1.1.2.2.2.1.2.2.2.1.1.1 IRB Roster
1.2.1.1.1.2.2.2.1.2.2.2.1.1.1.1 IRB Roster
1.2.1.1.1.2.2.2.1.2.2.2.1.1.2 All patient materials approved by the IRB & MOH with original stamp of approval (ICF's, Pt. Diaries, Advertisement, etc...)
1.2.1.1.1.2.2.2.1.2.2.2.1.1.2.1 Copy of all patient approved documents by the IRB and MOH
1.2.1.1.1.2.2.2.1.2.2.2.1.1.2.2 Original signed and dated Laboratory Ranges
1.2.1.1.1.2.2.2.1.2.2.2.1.1.2.2.1 Copy of Laboratory Ranges
1.2.1.1.1.2.2.2.1.2.2.2.1.1.2.2.2 Copy (Original if available laboratory director C.V., laboratory accreditation and certificates
1.2.1.1.1.2.2.2.1.2.2.2.1.1.2.2.2.1 Copy of laboratory director C.V. and laboratory accreditation and certificates
1.2.1.1.1.2.2.2.1.2.2.2.1.1.2.2.2.1.1 Original GMP Certificate (if applicable)
1.2.1.1.1.2.2.2.1.2.2.2.1.1.2.2.2.1.1.1 Original Insurance Policy Certificate
1.2.1.1.1.2.2.2.1.2.2.2.1.1.2.2.2.1.1.1.1 Copy of Insurance Policy
1.2.1.1.1.2.2.2.1.2.2.2.1.1.2.2.2.1.1.1.1.1 Copy of Insurance
1.2.1.1.1.2.2.2.1.2.2.2.1.1.2.2.2.1.1.1.2 Copy of Site Initiation Visit Confirmation Letter
1.2.1.1.1.2.2.2.1.2.2.2.1.1.2.2.2.1.1.1.2.1 Original Site Initiation Visit Confirmation Letter
1.2.1.1.1.2.2.2.1.2.2.2.1.1.2.2.2.1.1.1.2.1.1 Copy of Site Initiation Visit Report
1.2.1.1.1.2.2.2.1.2.2.2.1.1.2.2.2.1.1.1.2.1.1.1 Original Site Initiation Visit Report
1.2.1.1.1.2.2.2.1.2.2.2.1.1.2.2.2.1.1.1.2.1.1.2 Original confirmation letters for scheduled monitoring visits at the site
1.2.1.1.1.2.2.2.1.2.2.2.1.1.2.2.2.1.1.1.2.1.1.2.1 Copy of scheduled monitoring visit confirmation letters sent to site
1.2.1.1.1.2.2.2.1.2.2.2.1.1.2.2.2.1.1.1.2.1.1.2.1.1 Original monitoring visit report
1.2.1.1.1.2.2.2.1.2.2.2.1.1.2.2.2.1.1.1.2.1.1.2.1.1.1 Copy of follow up visit report
1.2.1.1.1.2.2.2.1.2.2.2.1.1.2.2.2.1.1.1.2.1.1.2.1.1.1.1 Original follow up report for monitoring visit
1.2.1.1.1.2.2.2.1.2.2.2.1.1.2.2.2.1.1.1.2.1.1.2.1.1.1.2 Copy of Close Out Visit confirmation letter
1.2.1.1.1.2.2.2.1.2.2.2.1.1.2.2.2.1.1.1.2.1.1.2.1.1.1.2.1 Original Close out visit confirmation letter
1.2.1.1.1.2.2.2.1.2.2.2.1.1.2.2.2.1.1.1.2.1.1.2.1.1.1.2.1.1 Original document of study medication destruction (sponsor specifies who is responsible for the destruction)
1.2.1.1.1.2.2.2.1.2.2.2.1.1.2.2.2.1.1.1.2.1.1.2.1.1.1.2.1.1.1 Copy of study medication destruction
1.2.1.1.1.2.2.2.1.2.2.2.1.1.2.2.2.1.1.1.2.1.1.2.1.1.1.2.1.1.1.1 TMF (Sponsor specifies who will be in charge)
1.2.1.1.1.2.2.2.1.2.2.2.1.1.2.2.2.1.1.1.2.1.1.2.1.1.1.2.1.1.1.1.1 Accountability logs: Sponsor always copies the logs but at the Close Out Visit the CRA takes the original from the site and leaves a copy
1.2.1.1.1.2.2.2.1.2.2.2.1.1.2.2.2.1.1.1.2.1.1.2.1.1.1.2.1.1.1.1.1.1 Accountability logs: Sponsor always copies the logs but at the Close Out Visit the CRA takes the original from the site and leaves a copy
1.2.1.1.1.2.2.2.1.2.2.2.1.1.2.2.2.1.1.1.2.1.1.2.1.1.1.2.1.1.1.1.1.2 ICF Log: Sponsor always copies the logs but at the Close Out Visit the CRA takes the original from the site and leaves a copy
1.2.1.1.1.2.2.2.1.2.2.2.1.1.2.2.2.1.1.1.2.1.1.2.1.1.1.2.1.1.1.1.1.2.1 ICF Log: Sponsor always copies the logs but at the Close Out Visit the CRA takes the original from the site and leaves a copy
1.2.1.1.1.2.2.2.1.2.2.2.1.1.2.2.2.1.1.1.2.1.1.2.1.1.1.2.1.1.1.1.1.2.1.1 Original Periodic and Annual Site Reports with approval stamp from the IRB & MOH
1.2.1.1.1.2.2.2.1.2.2.2.1.1.2.2.2.1.1.1.2.1.1.2.1.1.1.2.1.1.1.1.1.2.1.1.1 Copy of Periodic and Annual Site Reports
1.2.1.1.1.2.2.2.1.2.2.2.1.1.2.2.2.1.1.1.2.1.1.2.1.1.1.2.1.1.1.1.1.2.1.1.1.1 Copy of Periodic and Annual Site Reports
1.2.1.1.1.2.2.2.1.2.2.2.1.1.2.2.2.1.1.1.2.1.1.2.1.1.1.2.1.1.1.1.1.2.1.1.2 Site Delegation of Responsibilities Log: Original is Kept the site and at the Close Out Visit the P.I. signs the document and the CRA takes the original leaving a copy at the site
1.2.1.1.1.2.2.2.1.2.2.2.1.1.2.2.2.1.1.1.2.1.1.2.1.1.1.2.1.1.1.1.1.2.1.1.2.1 Site Delegation of Responsibilities Log: Original is Kept the site and at the Close Out Visit the P.I. signs the document and the CRA takes the original leaving a copy at the site
1.2.1.1.1.2.2.2.1.2.2.2.1.1.2.2.2.1.1.1.2.1.1.2.1.1.1.2.1.1.1.1.1.2.1.1.2.2 Original SAE Form and IRB/MOH response
1.2.1.1.1.2.2.2.1.2.2.2.1.1.2.2.2.1.1.1.2.1.1.2.1.1.1.2.1.1.1.1.1.2.1.1.2.2.1 Copy of SAE report
1.2.1.1.1.2.2.2.1.2.2.2.1.1.2.2.2.1.1.1.2.1.1.2.1.1.1.2.1.1.1.1.1.2.1.1.2.2.1.1 Copy of SAE Report
2 ETHICS COMMITTE/ MOH
2.1 SITE
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