Case Report Forms (CRFs) are a common data collection mechanism in clinical studies and are sometimes the original recording of study data. CRF completion is one of the earliest opportunities to assure accurate and complete data and to decrease downstream work associated with identification and resolution of data discrepancies. This chapter covers development, maintenance and implementation of instructions for CRF completion, also called CRF Completion Guidelines (CCGs). Recommendations in this chapter are based on ICH E6 R2, the MHRA GXP Data Integrity Guidance and Definitions, review of the literature and writing group consensus.
After attending this webinar, the participant should understand:
• The purpose of and regulatory basis for CRF completion guidelines
• The contents and organization of CRF completion guidelines
• Creation and maintenance of CRF completion guidelines
• Training clinical investigational sites or CRAs on CCGs
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 assessment deadline.
SCDM is authorized by IACET to offer 0.2 CEUs for this program.
Individual registration: $50 member / $100 non-member
Group registration (max. 10 people per group): $150 member / $300 non-member
Group Registration Policy: Any group registration allows up to 10 people to attend the webinar and to complete the webinar assessment. Credits will be granted on an individual basis upon successful completion of the assessment by the registered participants.
$50.00 - $300.00