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
Daily Weekly Monthly Never Other: __________ N/A room temperature – Secondary/Back-Up Temperature Monitoring and Review Is manual documentation of temperatures conducted on a daily basis? Yes No From which of the following secondary/back-up devices are temperatures manually recorded? Chart recorder Data logger USB data logger Integrated facility system Digital min/max thermometer Mercury min/max thermometer Other: __________ None On which days are temperatures reviewed and manually documented? (check all that apply) Monday Tuesday Wednesday Thursday Friday Saturday Sunday Official Holidays REFRIGERATED STORAGE- Primary Refrigerated Storage The type of refrigerator used as primary storage is: Scientific refrigerator Walk-in refrigerator Other: None or N/A (skip to ‘-20°C Freezer Storage’ section) Is the refrigerator located in the research pharmacy? Yes No If ‘No’, describe the location: Is access to the contents of the refrigerator limited to pharmacy staff only? Yes No Is the refrigerator supported by a generator or back-up power source? Yes No What can the refrigerator temperature be maintained? ___°C and ___°C REFRIGERATED STORAGE-
What can the -20°C freezer temperature be maintained? ___°C and ___°C Is the 20°C freezer a cycling (frost-free) or non-cycling freezer? Cycling Non-cycling -20°C FREEZER STORAGE- Additional -20°C Freezer Storage Is there additional -20°C freezer storage? Yes No (If ‘No’, skip to ‘-20°C Freezer- Primary Continuous Temperature Monitoring and Recording Device’ section.) The additional type of -20°C freezer is: Scientific grade -20°C freezer Walk-in -20°C freezer Other: Is the additional -20°C freezer located in the research pharmacy? Yes No If ‘No’, describe the location: Is the additional -20°C freezer supported by a generator or back-up power source? Yes No What range can the additional -20°C freezer temperature be maintained? ___°C and ___°C Is the additional -20°C freezer a cycling (frost-free) or non-cycling freezer? Cycling Non-cycling -20°C FREEZER STORAGE- Primary Continuous Temperature Monitoring and Recording Device The primary device used to continuously monitor and record the temperature of the -20°C freezer is a: Chart recorder Data logger USB data logger Integrated facility system __________ None The power supply of the device identified in the previous question is: Hard-wired Battery Operated Plugged-in to a power supply _________ The interval at which the temperature is recorded is: every _____minutes
For data captured electronically, what is the frequency the Site Research Pharmacist prints and reviews the temperature documentation for the primary device? Daily Weekly Monthly Never Other: __________ N/A For chart recorded data, what is the frequency which the Site Research Pharmacist reviews the temperature documentation for the primary device? Weekly Monthly Never Other: __________ N/A For chart recorded data, what is the frequency which the Site Research Pharmacist replaces the chart paper for the primary device? Daily Weekly Monthly Never Other: __________ N/A -20°C FREEZER STORAGE- Secondary/Back-Up Temperature Monitoring and Review Is manual documentation of temperatures conducted on a daily basis? Yes No From which of the following secondary/back-up devices are temperatures manually recorded? Chart recorder Data logger USB data logger Integrated facility system Digital min/max thermometer Mercury min/max thermometer Other: __________ None On which days are temperatures reviewed and manually documented? (check all that apply) Monday Tuesday Wednesday Thursday Friday Saturday Sunday Official Holidays -70°C FREEZER STORAGE- Primary -70°C Freezer Storage