Clinical data acquisition
||This article contains instructions, advice, or how-to content. (September 2009)|
Acquisition or collection of clinical trial data can be achieved through various methods that may include, but are not limited to, any of the following: paper or electronic medical records, paper forms completed at a site, interactive voice response systems, local electronic data capture systems, or central web based systems.
There is arguably no more important document than the instrument that is used to acquire the data from the clinical trial with the exception of the protocol, which specifies the conduct of that clinical trial. The quality of the data collected relies first and foremost on the quality of that instrument. No matter how much time and effort go into conducting the clinical trial, if the correct data points were not collected, a meaningful analysis may not be possible. It follows, therefore, that the design, development and quality assurance of such an instrument must be given the utmost attention.
The ICH guidelines on Good clinical practice (GCP) use the term ‘Case report form’ or ‘CRF’ to refer to these systems 1 . No matter what CRF is utilized, the quality and integrity of the data is of primary importance. The following recommendations are meant to assist in the design, development and quality assurance of the CRF such that the data collected will meet the highest standards.
For an extensive discussion regarding creation of CRFs and examples of actual data collection forms, see Data Collection Forms for Clinical Trials by Spilker 2 . The following is meant to highlight some of the most important points to consider during the design process.
- Design the CRF to collect the data specified by the protocol.
- Document the process for CRF design, development, approval and version control.
- Make the CRF available at the clinical site prior to enrollment of a subject.
- Document training of clinical site personnel on the protocol, CRF completion instructions and data submittal procedures prior to enrollment of a subject.
- Design the CRF along with protocol to assure collection of only the data that protocol specifies.
- Keep questions, prompts and instructions clear and concise.
- Design the CRF to follow the data flow from the perspective of the person completing it, taking into account the flow of study procedures and typical organization of data in a medical record.
- Avoid referential and redundant data points within the CRF whenever possible. If redundant data collection is used to assess data validity, the measurements should be obtained through independent means.
- Design the CRF with the primary safety and efficacy endpoints in mind as the main goal of data collection.
- Establish and maintain a library of standard forms.
- Make the CRF available for review at the clinical site prior to approval.
- Use NCR (no carbon required) paper or other means to assure exact replicas of paper collection tools.
- Clinical Data Interchange Standards Consortium (CDISC)
- Electronic Data Capture
- Clinical Data Management System (CDMS)
- Clinical Document Architecture (CDA)
- Health Insurance Portability and Accountability Act (HIPAA)
- Directive 95/46/EC on the protection of personal data
- Health Level 7
- Case Report Form
- Patient-reported outcome
- Data management
- Title 21 CFR Part 11
- SmartPen - technological system for digitally encoding and transmitting Case Report Forms
- Debbie Kennedy, CRF Designer, Canary Publications, ISBN 0-9531174-7-2
- Rebecca Daniels Kush (2003), eClinical Trials: Planning and Implementation, CenterWatch / Thomson Healthcare, ISBN 1-930624-28-X
- Spilker B.L. Schoenfelder J. (1991), Data Collection Forms in Clinical Trials Raven Press, New York.