GCP SBR Advanced Refresher reinforces the importance of concepts covered in the basic level GCP – Social and Behavioral Research Best Practices for Clinical Research course. This second-level course goes in-depth on more advanced GCP concepts (for example, specific GCP issues like monitoring, audits, inspections, and data and safety monitoring), expands upon the breadth of the investigator’s responsibilities, and explores topics relevant to social sciences research and behavioral trials not traditionally covered in GCP courses (such as when social behavioral research could be considered a clinical trial, social media use in research, and deception in informed consent).
CITI Program GCP training is used by over 1,600 institutions, (including many leading hospitals, academic medical centers, universities, and healthcare companies), to meet their GCP training needs. The National Institutes of Health (NIH)* requires completion of GCP training that demonstrates that individuals have attained the fundamental knowledge of clinical trial quality standards for designing, conducting, recording and reporting trials that involve human research participants.
This course also meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors when the following modules are completed:
- Overview of ICH E6 GCP for Behavioral Interventions and Social Science Research
- Investigator’s Role and Responsibilities in Behavioral Interventions and Social Science Research
- Informed Consent in Behavioral Interventions and Social Science Research
- Monitoring, Audits, Inspections, and Data and Safety Monitoring of Behavioral Interventions and Social Science Research
- In-Depth Review of ICH E6 and TransCelerate Minimum Requirements
Content in the GCP SBR Advanced Refresher is up to date with ICH E6(R2).
* NIH in fulfillment of their GCP training policy (Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials; NOT-OD-16-148) states that NIH-funded investigators and staff should be trained in GCP. The NIH does not endorse any specific training programs. CITI Program offers several GCP courses that are considered acceptable by many leading organizations to meet their training needs per NIH policy released on 16 September 2016.
Language Availability: English
Suggested Audiences: Social and behavioral investigators and staff
Organizational Subscription Price: Included with Good Clinical Practice series, available as part of an organizational subscription package or for $1,000 as an add-on to current subscriptions.
Independent Learner Price: $129 per person