When setting up a solution to manage your clinical trials, also known as an EDC solution (Electronic Data Capture), it’s important to avoid certain pitfalls in order to save time and guarantee optimum quality.
To help you avoid these mistakes, we’ve listed them below.
01
Security & Compliance
Check the compliance and various validations of the solution you are planning to use. Make sure the solution complies with regulations (21 CFR PART 11, HIPAA, GDPR, ISO 27001, HDS, ICH GCP…). This will ensure the security of collected data and patients’ personal data. For example, many solutions claim to be HDS-certified without actually being certified.
To be sure, ask for evidence of these certificates and compliance.
02
Defining needs
Ask your research teams about their specific needs, as they will be the first to be affected by the choice of an EDC solution for your clinical trials.
03
Allocated time
Define the necessary transition time and stick to it. This allows you to set a framework for all the people involved, and to set a clear target. In our experience, this transition can be achieved in just 30 days with Datacapt!
04
Users et Roles
It is important to precisely define the platform’s users and their roles (project manager, data manager, investigator, administrator, etc.).
This also includes tasks and documentation for system administration, study and form creation, and process implementation.
05
Form design
Don’t transcribe all your paper forms into digital (eCRF). It may seem surprising, but reproducing your paper forms identically on the digital solution is counter-productive and counter-intuitive. You need to rethink the way you build your forms so that they are simple and fluid. Easily set-up data validation, consistency checks and automatic alerts to reduce human error and guarantee optimum data quality.
06
Questions-Types
When designing forms such as eCRF or ePRO, don’t underestimate the value of using a variety of questions-types (Radio button, slider, calculation, multi-choice, date…). Using as many questions as possible will ensure that your patients’ answers are clear and precise. You’ll no longer have to deal with hazardous, erroneous, or even missing answers.
07
Structure & Templates
Structuring and harmonizing your forms and data collection will save you a considerable amount of time. Use the template function to save your forms and reuse them over and over again.
Choose Datacapt for your clinical trials and benefit from rapid implementation and a platform that fully meets your requirements in terms of security, flexibility, and user-friendliness.
