AE Adverse Event CAP Pathologists CLIA Clinical Laboratories Improvement Amendments CRFs Case Report CVs Curricula DMID Division of Microbiology and Infectious Diseases DMID-CAR DMID – Clinical Agents Repository FWA Federalwide Assurance GCP Good Clinical Practice IB Investigator’s Brochure ICH International Conference on Harmonisation IEC Independent Ethics Committee Investigational New Drug (Application) IRB Institutional Review Board JCAHO Joint Commission on Accreditation of Healthcare Organizations MOP Manual of Procedures OCRA Office of Clinical Research Affairs ORA Office of Regulatory Affairs PI Principal Investigator PID Participant Identifier SAE Serious Adverse SR Safety Report v
5 STUDY SPECIFIC PROCEDURES or MANUAL OF PROCEDURES This section (or alternate location if other file system is used) must contain the study specific procedures (SOP) or manual, if applicable. Each study specific procedure or Manual of Procedures (MOP) must have a Version number and date. All Versions used throughout the study must be maintained in the file. The Study Specific Procedures or Manual of Procedures may include the Laboratory Procedures Manual, Laboratory Specimen Handling instructions, test article handling and/or preparation, and Protocol-specific instructions. Note: Deviations from the Study Specific Procedures or Manual of Procedures must be documented in a similar fashion as Deviations of the Protocol. 6 SUBJECT SCREENING/ENROLLMENT LOG List all subjects considered for this (e.g., all subjects from your IRB/IEC approved institution that you screened for this study). A study number or screening number must be used on this list and an ID Code list that links those numbers must be kept. For study purposes, records cannot
9a RECEIPT OF TEST ARTICLE SITE: PROTOCOL NO.: ___________________ INVESTIGATOR: TO BE COMPLETED BY SUPPLY SOURCE NAME OF SUPPLIER: LABEL CODE NO. DESCRIPTION UNIT SIZE QUANTITY INITIALS TO BE COMPLETED BY SITE LABEL CODE LOT/LABEL NO. DESCRIPTION UNIT SIZE QUANTITY INITIALS 1. Was/were test article(s) received undamaged? Yes No 2. Has the shipment temperature appeared to have been maintained? Yes No 3. Was a temperature monitor included in the shipment? Yes No 4. If “Yes,” was the temperature monitor readable at the site? Yes No 5. If “Yes,” what was the readout? Min.____ Max.___ I HEREBY ACKNOWLEDGE THAT THE TEST ARTICLES LISTED WERE RECEIVED ON ________________________________ AT _____________ AM/PM (MM/DD/YY) SIGNATURE
9b TEST ARTICLE ACCOUNTABILITY RECORD NAME OF INSTITUTION _______________________________ PROTOCOL No. ____________________________________________________ DRUG NAME, DOSE FORM & STRENGTH ____________PROTOCOL ______________________________________________________ PRINCIPAL INVESTIGATOR ________________________________ DATE SUBJECT ID # (PID) DOSE DISPENSED RECEIVED BALANCE MANUFACTURERS LOT # RECORD INITIALS DATE RETURNED AMOUNT RETURNED INITIALS 27001001 800mg QD 38 tabs 372 TA PF 1234 SB 8 tabs SB
9e DISPOSITION OF TEST ARTICLE AT END OF TRIAL SITE: PROTOCOL: ______________________ INVESTIGATOR: I HEREBY ACKNOWLEDGE THAT THE REMAINING TEST ARTICLES LISTED BELOW WERE DESTROYED ON _________________________________ (MM/DD/YY) TEST ARTICLES WERE DESTROYED. SPECIFY METHOD: LABEL CODE LOT/LABEL NO. DESCRIPTION UNIT SIZE QUANTITY INITIALS SIGNATURE (MM/DD/YY) SIGNATURE (MM/DD/YY)
package insert for the regulatory file. sponsors are required to notify sites of IND Safety Reports that have been submitted to the FDA. These IND Safety Reports must be submitted to the IRB/IEC and filed with the IB. Any other informational letters issued by the manufacturer to investigators must also be filed in this section. 21 PERIODIC REPORTS AND ANNUAL RENEWALS This section (or alternate location if other file system is used) must include the Principal Investigator's periodic reports to the IRB/IEC and any other reports to the IRB/IEC, as well as annual and/or periodic Approvals from the IRB/IEC. Maintain the entire packet together in the file – the submission letter, submission report package, and IRB/IEC Approval. It is suggested that the newest packet should be in the front.