Provide the address for the physical location of the research pharmacy. This address cannot be a P.O. Box. Complete the table below and indicate whether the documents are maintained electronically or hard copy in the pharmacy. Format Does anyone other than Are the authorized pharmacy documents all that apply) Document personnel have access organized by Hard Electronic N/A to these documents? protocol? Copy Most recent version of a Yes No protocol Accountability records Yes No Yes No Product Orders Yes No Yes No Invoices Yes No Yes No Packing slips Yes No Yes No Returns to DMID Clinical Yes No Yes No Agents Repository (CAR) Verified Study Yes No Yes No Product Destruction Forms Study treatment assignment information Yes No Yes No and/or randomization records of custody records Yes No Yes No Original prescriptions, prescribing order, or Yes No Yes No request for study product Current version of the Investigator’s Brochure (IB) or product Package Yes No Insert (PI) for the study products Written communications Yes No Yes No with clinic staff Written communications Yes No Yes No with DMID
Provide the address for the physical location of the research pharmacy. This address cannot be a P.O. Box. Complete the table below and indicate whether the documents are maintained electronically or hard copy in the pharmacy. Document Format all that apply) Does anyone other than authorized pharmacy personnel have access to these documents? Are the documents organized by protocol? Hard Copy Electronic N/A Most recent version of a protocol Yes No Accountability records Yes No Yes No Product Orders Yes No Yes No Invoices Yes No Yes No Packing slips Yes No Yes No Returns to DMID Clinical Agents Repository (CAR) Yes No Yes No Verified Study Product Destruction Forms Yes No Yes No Study treatment assignment information and/or randomization records Yes No Yes No of custody records Yes No Yes No Original prescriptions, prescribing order, or request for study product Yes No Yes No Current version of the Investigator’s Brochure (IB) or product Package Insert (PI) for the study products Yes No Written communications with clinic staff Yes No Yes No Written communications with DMID Yes No Yes No
DMID%20Study%20Product%20Management%20Plan.docx