Tuesday, December 1, 2020
Home Clinical Data Management Important 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)
- Advertisement -

LEAVE A REPLY

Please enter your comment!
Please enter your name here

eleven + eight =

Most Popular

Eisai and Wren Therapeutics Enter Into Research Collaboration Agreement for Drug Discovery for Synucleinopathies

November 30, 2020: Eisai and Wren Therapeutics announced that the companies have entered into an exclusive research collaboration agreement aiming to advance...

AstraZeneca agreed to sell rights to Crestor to be divested to Grünenthal in Europe

December 01, 2020: AstraZeneca has agreed to sell the rights to Crestor (rosuvastatin) and associated medicines in over 30 countries in Europe, except the...

AstraZeneca’sForxiga approved in Japan for chronic heart failure

November 30, 2020: AstraZeneca’s Forxiga (dapagliflozin) has been approved in Japan for the treatment of patients with chronic heart failure (HF) who are receiving...

Moderna Announces the EC Approval for Initial 80 Million Doses of mRNA Vaccine Against COVID-19

November 25, 2020: "Moderna, a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines...