Documents

SPONSOR

1. Original CDA

   • Copy of CDA
   • Original Feasibility Form
     • Original Site Qualification Visit Form
       • Original Selection Visit Form
         • 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

2. ETHICS COMMITTE/ MOH

   • SITE