Program Information

'Hot Topics' and Practical Considerations for Protecting Human Research Participants

This three-day conference for Clinical Research Professionals will study, explain and discuss how ICH GCP and the Code of Federal regulations guide and direct investigator responsibilities, IRB management issues, audits, the informed consent process, and administrative activities in today’s evolving environment. The attendee will understand and be able to convey the responsibilities of these very important functions and the complementary role of the clinical researcher as a fundamental contributor to successful clinical research and the protection of research subjects.
The program will focus on the relationships among clinical trial staff, investigators, IRBs the FDA, CROs and sponsors. The conference will highlight areas that present challenges to sponsors and investigational sites: writing informed consent documents, the informed consent process, use of genomic data, future use of stored bio-specimens, risk-based monitoring, electronic communication and electronic documentation, and research fraud. The use of REDCap for operational and personal management tracking for multi study tracking purposes as well as electronic consent use towards personalized informed consent will also be explored. The program will identify best practices and strategies to provide potential solutions for these challenges.

Register today - Space is limited!


Please note, this workshop is intended to be highly interactive.  Video attendance is strongly encouraged.  Once you register, you will be able to install and test the appropriate software to ensure your audio and video will work properly during the program.  Please be sure to give yourself time to address any technical issues that might arise.  Please contact us with any questions or concerns at office@socra.org. 

 Dates:

Tuesday, October 5 to Thursday, October 7, 2021 

Time:

12:00 to 5:00 pm ET*

*All times in Eastern Standard Time Zone

Registration Fees:
  • Member Fee- $305
  • Non-Member Fee- $380
    Non-Member Fees include a non-refundable one-year membership in SOCRA
Continuing Education Credit Hours:

SOCRA designates this educational activity for a maximum of 13.0 Continuing Education Credits for SOCRA CE and Nurse CNE. SOCRA designates this live activity for a maximum of 13.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Accreditation Statements:

CME for Physicians: The Society of Clinical Research Associates is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
CNE for Nurses: Society of Clinical Research Associates is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation.

SOCRA Course Series: 300