Using E-Content Technology in Clinical Trials
- Discuss how to provide patients clear and easy-to-understand clinical trial information so that they are truly informed to make a decision to participate in a research study.
- Discuss two case studies and how to implement E-Consenting using a variety of technologies.
- Review Ethics Committee expectations and regulations including FDA Guidance document to improve review/approval process & reduce inspection findings.
- Compare traditional methods with the use of E-Consenting and the pros and cons of both applications
Sabrina Ramkellawan has more than 15 years of experience in conducting clinical trials in a number of environments including overseeing CROs, in pharmaceutical companies and also at investigator sites (Physician Clinics). She has worked in various roles including Research Nurse, CRC, CRA and various management positions. She is currently an Independent Consultant that helps sites, research organizations and pharmaceutical companies with the conduct of clinical trials. She has experience with utilizing technology in clinical trials including being the clinical lead in the implementation of an Electronic Data Capture (EDC) system at a CRO, implementing a new recruitment database to improve patient recruitment and has worked on three research studies that have utilized electronic consent.