Documents

SPONSOR

Original CDA
1. Copy of CDA
2. Original Feasibility Form
  1. Original Site Qualification Visit Form
    1. Original Selection Visit Form
      1. A Contract with Original Signatures
        A Contract with Original Signatures
        Copy of IB and P.I. Acknowledgment Form
        Original IB Acknowledgment form
        Protocol and Protocol Signature Page Copy
        Original P.I. Protocol Signature Page
        Original CV's with Signature in Sponsor's Format
        Copy of GCP Certificates and Licensures,
        Copy of GCP Certificates and Licensures
        Copy of GCP and Licensures
        Copy of Submission letters with IRB/MOH Approval
        Original Submission letters with Approvals
        Copy of submission letters with Original IRB/MOH Stamp of Approval
        Wet ink Financial Disclosure Forms (if applicable)
        Copy of Financial Disclosure Forms (if applicable)
        Original 1572 FDA Form (if applicable)
        Copy of 1572 FDA Form (if applicable)
        Copy of IRB Roster
        IRB Roster
        IRB Roster
        All patient materials approved by the IRB & MOH with original stamp of approval (ICF's, Pt. Diaries, Advertisement, etc...)
        Copy of all patient approved documents by the IRB and MOH
        Original signed and dated Laboratory Ranges
        Copy of Laboratory Ranges
        Copy (Original if available laboratory director C.V., laboratory accreditation and certificates
        Copy of laboratory director C.V. and laboratory accreditation and certificates
        Original GMP Certificate (if applicable)
        Original Insurance Policy Certificate
        Copy of Insurance Policy
        Copy of Insurance
        Copy of Site Initiation Visit Confirmation Letter
        Original Site Initiation Visit Confirmation Letter
        Copy of Site Initiation Visit Report
        Original Site Initiation Visit Report
        Original confirmation letters for scheduled monitoring visits at the site
        Copy of scheduled monitoring visit confirmation letters sent to site
        Original monitoring visit report
        Copy of follow up visit report
        Original follow up report for monitoring visit
        Copy of Close Out Visit confirmation letter
        Original Close out visit confirmation letter
        Original document of study medication destruction (sponsor specifies who is responsible for the destruction)
        Copy of study medication destruction
        TMF (Sponsor specifies who will be in charge)
        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
        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
        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
        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
        Original Periodic and Annual Site Reports with approval stamp from the IRB & MOH
        Copy of Periodic and Annual Site Reports
        Copy of Periodic and Annual Site Reports
        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
        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
        Original SAE Form and IRB/MOH response
        Copy of SAE report
        Copy of SAE Report
ETHICS COMMITTE/ MOH
1. SITE

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	Erstellt von Debbie Farkas vor mehr als 9 Jahre