Case: an open randomized clinical trial of phase 1 in 2 parallel groups with the participation of 20 healthy volunteers.
OnlineCRF has created an EDC system for data collection and study control.
Audit of provided documentation.
Definition of the basic requirements for an EDC system based on the Protocol and CRF.
Using the checklists, a full audit of the project documents was carried out: Protocol, CRF. The need for a significant change in the initial CRF for adjusting the eHRC and introducing the fields of automatic verification (validation) has been identified.
Adapt the CRF to configure the EDC system.
The Sponsor provides a paper-based CRF in a form unsuitable for configuration of the system.
A paper version of the CRF was annotated. The necessary hiden fields, automatic value checks, cross-check are registered. An annotated CRF was further used to configure the system.
Implementation of manual randomization.
One of the requirements of the Sponsor is the ability to manually enter the randomization numbers that were generated by the external system into the EDC system.
The randomization module has been redesigned to meet requirements. The research doctor has the opportunity to manually assign each patient a randomization number.
In this case users needed round-the-clock technical support. Due to the peculiarities of phase 1 projects: short duration, the intervals between visits were 1 day. According to the requirements of the Protocol, the CRF must be completed strictly on the day of the visit, and if it is late, it must be blocked.
The OnlineCRF 24\7 team processed requests and solved users' technical problems. The support process was set up so that the doctor could get an answer within 30 minutes and be able to fill out the visit form on time.