Thursday, October 21, 2021
HomeClinical Data ManagementImportant data points in Protocol for CRFs Creation (CDM Prospective):

Important data points in Protocol for CRFs Creation (CDM Prospective):

Reading of whole protocol is quite important and indispensable act but by keeping following points in mind, one can read protocol with more clarity and productivity.

  • Phase, Indication, Scope of study
  • Age, Sex, Demography and Race
  • Informed consent form
  • Inclusion Exclusion Criteria and Re-screening criteria.
  • Study design
  • Study arm
  • Study drug-Formulation, Dosing frequency
  • Dose reduction, Increase, interruption or Discontinuation criteria
  • Visit Schedule and Assessment (Please see the study arm related assessment if any)
  • Assessment to be performed in unscheduled visit or based on investigator judgement.
  • Labs and Image assessments
  • Drug dosing time points, Biomarker and PK data collection time (eg. Predose, post dose)
  • Adverse Event and SAE (serious adverse event) definition and reporting guidance and Severity criteria
  • Concomitant Medication and procedure reporting guidance
  • Medical History reporting guidance
  • Tumor Assessment criteria in oncology study (i.e RECIST)
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