Site preparation and infrastructure development are integral components to conducting successful clinical research. Site assessments are visits made to your site by ICSSC team members to ensure that the Principal Investigator (PI) and study team have everything in place to conduct your study or studies according to Good Clinical Practice.
The site assessment team, which may include a Clinical Trialist, Data Manager, and/or Biostatistician will travel to your site and tour your facility assessing such characteristics as qualification and skills of study personnel; facilities and equipment including laboratories and computer systems; record keeping systems; data collection, entry, and management capabilities; data analysis capabilities; and information technology systems i.e. Internet connections. Quantity also plays a part in site assessment visits and the team will assure you have adequate personnel as well as other needed resources to conduct your clinical research study. Team members will meet with you and your staff to review protocol requirements and site responsibilities for the study. Site visits generally last at least two days, and it will depend on the number of clinical studies and other factors.
As with all research, thorough preparation is an essential element of a successful clinical research study. Site assessment visits prepare the PI and staff to meet all requirements for conducting each study. At the conclusion of the visit, the PI will know what specific steps, if any, are needed to meet the applicable requirements.
The PI may request a site assessment visit by completing the Request for Assistance form or by contacting your DMID Program Officer. DMID may also initiate a site assessment visit to your facility. Once a visit has been jointly approved, someone from the ICSSC team will contact you to arrange the visit.
In preparation of a site assessment visit, the PI should assure all staff to be working on the study are available and be prepared to conduct a thorough facility tour for the ICSSC team. This should include all areas of the research including exam rooms, laboratories, data entry areas, computers, etc. The PI should also have available for review essential documents such as procedure manuals or standard operating procedures and site files. A meeting area should also be available to discuss questions and findings during the visit.
At the end of the visit, the members of the ICSSC team will meet with you and any staff you wish to share the team's findings on what things are going well and what areas (if any) need improvement. The team will provide you with guidance on those areas needing attention and make recommendations on how to improve them. They will direct you to available resources when possible and convey a sense of relative urgency and priority for specific recommendations. The team will write a report and provide a copy of it to you as well as to DMID staff.