Clinical data management is the process of collection, cleaning, and management of data in compliance with regulatory standards. It is an important part of any research study. Every investigator initiated trial (IIT) should have a clinical data management plan and support of a research study assistant. Statisticians are available to assist in the development of the data management plan by offering guidance on: selecting the right electronic data capture system, the best data collection methods, data entry practices that ensure consistency with paper CRFs, data validation methods and proper transfer of data for statistical analysis. However, biostatisticians are not taking responsibility for data management.
Related Information and Guidelines
Electronic Data Capture Systems (EDC)
- eRAP - a fee for service web-based application that allows you, as an investigator, to have a custom built database.
- RedCAP – a no-fee self-service web-based application that allows investigators to design your own database.
Case Report Form (CRF) Design
- Here you will find CRF templates consistent with FDA standards. These forms serve only as templates and should be edited to meet study data collection needs as described in the protocol.
- Double – Double data entry ensures better consistency with paper CRFs.
- Embed Range and Logic Checks in the EDC system to ensure data validity.
- Please create queries and run routinely to ensure ongoing quality control.
- Discrepancies flagged during the data validation and/or double data entry processes need to be reviewed and resolved with documentary proof.
- Coding for Adverse Events should be done using the Medical Dictionary for Regulatory Activities (MedDRA). To request access to MedDRA email firstname.lastname@example.org.
- Coding for Medications should be done using the WHO Drug Dictionary Enhanced (WHO-DDE)
- Coding for Adverse Reactions should be done using WHO-ART
For clarification of any of the above data management activities please consult the NIH guidelines
How long does it take?
All requests received through eRAP will be assigned to a TCI-BSRF statistician within two business days. Once assigned, a statistician will respond to your inquiry within three business days to arrange for the first meeting. Timeline for the work to be done will be discussed in this meeting. For protocols, movement to PRMC requires approval from the ‘Biostatistics Design Workshop’, a committee of all statisticians in the TCI-BSRF that meets weekly on Thursdays from 2-3 pm. For grant applications, time for development of the statistical sections ranges between 2-4 weeks depending on the readiness of the proposal in terms of having all information needed for writing the statistical sections.