In OnCore, at the patient data entry level, we have 7 important dates that need to be entered. Between those dates we have: (the consent date, eligibility date, on study date, on treatment date, off treatment date, on follow up and off study date). These dates are not only important for patient record purposes, they also drive:
- Accrual reporting to NCI
- SRC accrual reviews
- DSMC reviews for studies with active patients (on treatment)
- Enrollment log for regulatory files
The following is a brief definition of what represents each date.
|1. Consent Date
|Consent date is the date the subject signed the consent form.
|2. Eligibility date
|Eligibility date is the date when the patient is confirmed to be eligible for the study.
|3. On Study date **Important: If your subject is NOT ELIGIBLE they will NOT have an On-Study date.
|On Study Date is the date of first study specific Treatment/Intervention performed after eligibility has been established. The On Study Date is required in order for the participant to be counted as accrued.
|4. On Treatment date
|On Treatment Date is the date when the patient first receives the study intervention (investigational product, device or other non-therapeutic intervention). For crossover studies, multiple dates can be entered.
|5. Off Treatment date **Note: Pt can still have research related follow ups after coming off treatment but remain on study.
|Off treatment date is the date when the last research Treatment/Intervention is completed for the purposes of final collection of data for the primary outcome.
|6. On Follow up date **Note: Not all studies will have a follow up sections defined in the protocol.
|On follow up date is the first follow up visit date as defined by the protocol and it will be on or after the Off-Treatment date.
|7. Off Study date
|Off Study date is the date the study subject stops receiving the study Treatment/Intervention or the date in which no further interaction with the subject is required.