Sponsors assessing your readiness to participate in research will conduct on-site qualifying visits to determine if your facility meets study requirements. A dedicated research area within your practice is ideal; if this is not feasible at first, ensure that the space you are using is not only functional for research purposes, but would meet the basic requirements for most clinical trials.
You only get one chance to make a first impression. The areas where subjects will be seen and research office activities will take place should be clean and well-organized. The waiting area for study subjects should be comfortable and well-lit.
Secure Investigational Product (IP) Storage
This applies to any area where IP will be stored, i.e., doctor’s office, pharmacy, etc. Secure means limited access and out of the general flow of patients and staff. Although federal regulations do not require it, most sponsors will require these rooms or cabinets be locked. If your study includes a controlled drug, the storage area must be locked.
Refrigerator, freezer and shelving to store products. Consider locking cabinets to increase security and minimize dust and clutter. Refrigerators should be clearly labeled for food, specimens, or study drug.
Thermometers. Protocols will state the temperature range for investigational drug storage. Demonstrate your compliance with this requirement by providing daily documentation of the temperature of the area where drug is stored.
Backup plan for loss of electricity. Consider how you would maintain storage requirements if you lost electricity, including the loss of air conditioning if you live in a hot/humid climate.
Exam rooms should comply with local and state requirements, if any, and OSHA requirements. http:// www.osha.gov
Other Storage Areas
There should be dedicated space to house other study-related materials:
- If a central lab will be used for a study, all supplies necessary to obtain biological specimens will be provided to the site.
- Filing cabinet(s) for storage of study-specific regulatory files or binders and other study-related documentation.
- Post-study storage of materials (if your space is limited, you may need to identify climate-controlled off-site storage space).
Work Space for Study Coordinator and Monitor
The study coordinator will need dedicated office space to meet with potential and enrolled subjects and to conduct the operational aspects of the study (i.e., budget development, regulatory document completion, transcription, etc.).
Many studies will require frequent on-site visits by the sponsor’s or the CRO’s monitor/Clinical Research Associate (CRA). The ideal space for a monitor is in a quiet location where confidentiality of other studies is not compromised, and will provide access to medical records, the internet, and enough desk space for a laptop. In addition, easy access to a telephone and copier are beneficial.
Clinical Laboratory Improvement Amendments (CLIA) Certification. If your site has its own laboratory, sponsors will require documentation of a CAP or CLIA Certificate or a Certificate of Waiver. http:// www.cms.hhs.gov/clia/
Dangerous Goods Training Requirements. Any site that is preparing dangerous goods for shipping (e.g., infectious specimens, dry ice) must complete Shipping Infectious Substances/Dangerous Goods training.
Document that your equipment has been maintained/calibrated according to manufacturer’s specifications. This includes any equipment used for patient assessments.