Clinical Research Data Management is critically important to ensure the generation of high quality, reliable, and statistically sound data. A Data Management Plan is a tool used to map the location (during and after the trial) of all collected data and samples to support the trial, to describe the timely Quality Control process which helps to ensure complete and accurate data, and to identify the personnel who will be responsible for managing the data. Study team members are involved in the management of research data from study start to study closure.
The NINDS Intramural Program utilizes an electronic data capture system called CiSTAR (Clinical Informatics System for Trials and Research).
Getting Started with Data Management and CiSTAR
At time of Science Review Committee (SRC) Submission
- The PI will complete and submit the Phase 1 Data Management Plan (included with the SRC packet)
- The PI and study team will review the CTU Data Management SOP
- The CTU Lead, QA and Data Management Office will review the submitted Phase 1 Data Management Plan document and assign the appropriate staff (e.g. data manager) to the protocol.
Following SRC approval
- A member of the Quality Assurance team will contact the study team to facilitate the development of the Phase 2 Data Management Plan. During the Phase 2 meeting, the following will be discussed:
- Identify the origin of all source data, including each eligibility criterion, and determine the type and location of source documentation collected during the study (mapping the data)
- Identify which data will be captured in the electronic database, e.g., CiSTAR or other
At time of IRB submission
- The assigned Data Manager will contact the PI/Study to schedule the Phase 2 Data Management Meeting for eCRF creation.
- During the Phase 2 meeting, the following will be discussed:
- Identify all eCRFs to be used for data capture and any necessary rules, e.g., calculations, hiding elements, to optimize data collection
- Study team must obtain all applicable licenses in advance of eCRF completion
- The PI must complete the PI questionnaire which identifies all investigators requiring access to the CiSTAR database and their respective role(s).