Request from the site
Can the SSL support in development of source document worksheets and support in the development of SOPs?
Our Solution
As we have several site support liaisons in our team that had already experience in clinical research because of their previous on the job experience as research nurse, we were able to support the site with the development of the worksheets. This was always in collaboration with the on site clinical research coordinator and in review by the investigator.
For the development of the SOPs we included our QA. Also here, the QA support had worked for a clinical research site in her first 4 years of clinical research experience. With her 10 years clinical research experience in total, and in collaboration with the Lead for QA at the research site, they were able to develop and finalize all required SOPs that were deemed necessary for this site to perform the clinical studies.
Outcome
Due to the collaborations and communications with one of our team members and a team member of the site, they were able to increase the overall quality of the source documentation and they were able to finalize all SOPs required.