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CRF Design in CT


CRF Definition Data entry from patient data (normally for ONE patient)
ICH GCP: CRF Design Documentation and filling version controlled, QC
ICH GCP: CRF Fill out By investigator only, incl. approval of all changes
CRF Design: pCRF Paper CRF, predominant data entry method in Ct of all phases
CRF Design: IVRS/IWRS Interactive voice/web response system Used for randomization, study drug ordering, SD distribution, patient diaries, process tracking
CRF Design: iCRF Scanning, Reading, Verification
What are the functions & impact of the CRF? * method for structured data collection *Determines the course of the study *Key role for structuring activities *Mainspring foe the whole study conduct
List some CRF target groups Study staff Patients Medical staff at CRO CRAs data Management Team Statistics MW RA Quality assurance Quality management drug Safety
What is the relationship between the protocol and the CRF? The CRF is developed according to the protocol of the CT to reflect the need of the protocol in collecting the appropriate data for eact study subject.
What are the four sections of the protocol that are especially relevant for CRF development? -study flowchart/ visist schedule -Inclus./Exclus. criteria -Study Procedures (Methods) -Safety & Efficacy Data
What are the technical requirements for CRF design? -Capable workstation -Large/ High resolution monitor -DTP program -Printer -Drivers for keyboard + printer -Fonts -Applications/ Tools -Training
Basic CRF design principles -Distinct identifiers -Instruction for Data Collection -Simple Phrasing -Detailed Incl./Excl. Criteria -Consider global studies (language:English) -Clear Structure -Easy to fill out -Chronological CRF pages -Short & definite
Basic CRF design principles Cont. -Avoid duplicate data collection -PI date and Signature mandatory
Potential pitfall in CRF design? -Merging data fields in one single page -Splitting info over 2 or more pages -unusual phrases or abbreviations -Calculation of CRF forms
Things to Consider during CRF Review? WHY: evaluability of collected data WHO: Target groups WHEN: After protocol final & Before site initiation HOW: read protocol, make notes, comments, reasons for change
Created by: marlice