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)
