A Barnett Interactive Web Seminar offers you a seamless, secure, multimedia learning experience. These live, instructor-led sessions are designed to be highly interactive, and can be attended by individual attendees or groups at one low cost. No travel, no travel expenses, and no time away from the office!
Case History Maintenance in Clinical Trials
Upcoming Courses
The FDA requires investigators to complete and maintain adequate and accurate case histories for every research subject, including all pertinent information that will aid in reconstructing and evaluating the trial source data. In this web seminar, we will define what pertinent data is and what the requirements are for the maintenance of the case histories. We will also review the importance of understanding and implementing the ALCOA standard, which ensures that records are attributable, legible, contemporaneous, original, and accurate, whether they are paper or electronic.
- Review what is required as pertinent source for any clinical trial
- Present the required characteristics for any case history (ALCOA)
- Identify the requirements for case history maintenance
- Site Research Managers
- Investigators
- Clinical Research Associates/Monitors
- Study/CRA Managers
- Clinical Research Coordinators
- Sponsors/CROs
Sandra “SAM” Sather, M.S., B.S.N., C.C.R.A., C.C.R.C.
Click here for complete trainer biographies
$695
Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call 1-800-856-2556 for pricing.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE#: 0778-0000-11-082-L01-P. Released: 8/11.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.
