Data Management (CRFS and Source)
Study visits and procedures are structured in accordance with the study protocol to collect specific data points. Prior to each study visit, it is important to review the research protocol to identify all of the scheduled visits and procedures to be completed. This will help ensure that the site is prepared for each study visit and will have the necessary staff, equipment, and supplies available.
During each subject study visit, the research team will document the details of the tasks or procedures completed and any other pertinent research information in a source document. Utilization of a source document will help ensure protocol and regulatory compliance. Source documents are the original records of participant information. Please note that any form of documentation can be used as a source document and is subject to review when validating the integrity of data collection and analysis. Common source documents are participant medical records, phone encounters or notes, lab and diagnostic test results, participant diaries and specific research worksheets used to document key research data elements.
Case Report/Record Forms (CRFs)
Most industry-sponsored trials will provide paper Case Record Forms /Case Report Forms (CRFs) or access to Electronic Case Report Forms (eCRFs). The CRFs identify all of the data elements required by the sponsor and should correlate with the required data elements outlined in the protocol. Study site staff transcribes information from relevant source documents to the CRFs or eCRFs.
- All paper entries should be completed legibly, preferably in black or blue ink
- The Principal Investigator (PI) or their designee(s) may enter data on the CRFs and make corrections to the original CRFs as long as they are listed on the Authorized Representative Signature Record (Site Signature Log).
- Only acceptable medical terminology and approved institution abbreviations should be used.
- Avoid leaving blank data fields, using question marks, and using zeros as a response on CRFs. Determine the acceptable abbreviations to be used for the following scenarios: data not available, data not applicable and not done.
The study monitor (CRA) or central data coordinator will often review the CRFs for legibility, completeness, and consistency. Any data that is missing or errors identified by the study coordinator or monitor will need to be resolved. For some studies, this will be completed before the data can be sent to the Contract Research Organization (CRO) or Sponsor. Other studies may use data verifiers that screen all data fields and generate queries that are sent to the study center requesting corrections to the primary study document and electronic correction in the database. The explanation of missing data or data irregularities, including deviations from study protocol may require an explanation in the form of a memo/note to file.
Corrections to any CRFs and related study documents should be done using the following guidelines:
- A single line through the original data error, which will allow the data to remain legible (DO NOT erase, write over or use whiteout)
- The data corrections should be documented in ink, initialed and dated by the researcher completing the correction.
Requesting Medical Records
The study protocol will indicate when medical record information is necessary to meet the study requirements. Medical record information can be obtained by requesting a general medical release form to be signed by a study participant from whom the information belongs. This form is called the Authorization For Release of Medical Information. It can be used to request medical information that exists at a non-OSU site or to request specific medical information from OSU.
The medical release form will indicate the institution or provider from whom the information will be requested, the date of service and the specific medical information being requested. Additionally, the medical release form will specify the institution requesting the information and the principal investigator conducting the research. Medical release forms generally have a limited number of days to be used before they expire; OSU Authorization for Release of Medical Information is valid for 365 days from the date of patient signature.
At The Ohio State University, the Department of Medical Information Management can help provide the information needed for research. There are many electronic records such as IHIS and e-results that contain source documents that may be necessary to access for the purpose of extracting specific research data points. Please contact MIM prior to accessing records for research studies as you may need to complete additional documents or request access to these electronic systems.
- MIM: Research and Medical Records Information
- Authorization For Release of Medical Information
- Statement of Confidentiality
- Request for Research Access to Health System Clinical Information
Data Collection Tools
For investigator-initiated research studies, the research team is responsible for identifying the tools and mechanism for data collection and analysis. It is helpful to always have a biostatistician involved in the development of the tools and determination of data points that must be analyzed to support the research study objectives. Data can be collected and analyzed in simple programs like Excel or more complex research data management systems. If a simple program like Excel will be used, it must be password protected, have limited access to key personnel involved in the research study and be stored as stated in the IRB approved protocol, explaining how confidentiality of patient records and research data is protected. It is recommended that secure data management systems are utilized for human subjects data collection.
REDCap is an open source tool that provides study staff with tools to manage projects, participants, and research data. The CCTS can assist researchers to develop studies utilizing REDCap.
StudyTrax provides researchers with web-based tools to design and manage clinical and community studies. StudyTrax permits the user to build data collection forms as web pages. StudyTrax comes with built-in report and dataset generators; data can be exported to SAS or SPSS formats as well as to Excel or Word. Additionally, StudyTrax explicitly supports multicenter trials with an option to define sites.
Maintenance and Storage of Research Records
Research records should be stored according to IRB requirements for at least three years after the completion of the research study or longer if required by the sponsor. FDA regulations state that study records must be stored for at least two years past the date of approval of a New Drug Application (NDA) or discontinuation of the research study if an NDA will not be submitted by the sponsor.