Do you ever wonder what happens to the data after database lock? Then this webinar is tailored for your needs!
You will gain a significant understanding of how clinical trial data is reported in the sections of the Clinical Study Report and Annual Reports, as well as in the product insert and advertisements.
Participants will benefit from attending this webinar by gaining an understanding of the reporting requirements for the clinical study data in the CSR, AR, product label, package insert and advertisements. Participants will gain an understanding of the overall big picture of the data flow in clinical trials.
1. Describe the sections of the Clinical Study Report (CSR) for particular clinical data
2. Provide the necessary data for the Annual Report (AR) sections
3. Discuss the impact of data on the product label
4. Describe the data that is included in the package insert
5. Understand the requirements of data in advertisements
This webinar is tailored for intermediate and/or advanced clinical data professionals who are looking to gain a better understanding of the overall process flow for data in clinical trials.
Candace Friend Shelton CCDM, CCRA is currently the Vice President of Clinical Operations at Sanguine Biosciences, a leading technology company providing services to the personalized medicine and biomedical research market.
Candace has 25 years of clinical trial experience working in diverse positions, therapeutic areas, and companies. She is a published author in Nature, Cell and NEJM and a frequent speaker at conferences and workshops. Candace is known for her expertise in clinical operations, clinical data sciences, and being a change-agent by creating innovative disruptive solutions for clinical research.
Participants are eligible to receive CEUs upon attendance and successful completion of a web-based assessment within 30 days after the webinar. CEUs are not granted after the 30-day assesment deadline.
SCDM is authorized by IACET to offer 0.2 CEUs for this program.