A Case Record Form or CRF is a document designed in consonance with the Protocol, to record data and other information on each trial subject. The CRF should be in a format that allows accurate input, presentation, verification, audit and inspection of the recorded data. CRFs can be either in a paper or an electronic version, and both are acceptable under the Indian Good Clinical Practice guidelines.
Design of the CRF
The CRF should facilitate the collection of all the critical data required by the Investigator and the research team. In addition, the design should facilitate accurate recording and reporting of all data. The CRF should ideally be designed in collaboration with the research team, including the Principal Investigator, Biostatistician, Database developer/programmer, Data Manager, Clinical Operations Manager, etc. Before finalising the questions that are to be included, it is advisable to review and pilot the CRF.
The design of the CRF should be such that it facilitates data collection, and helps in maintaining data integrity. Some important points to consider while designing the CRF:
- The CRF should be designed in a user-friendly manner, considering the needs of all who will be involved in data handling (investigator, biostatistician, trial monitors, data manager, data entry team, etc.) specially the end user.
- The safety related modules in the CRF (for recording Adverse Events and Serious Adverse Events related information) must be customised and appropriate as per the trial/study being conducted. Questions to be included in these modules should ideally be selected from a standard library.
- The efficacy related modules in a CRF are specific to the therapeutic area and protocol. These are considered to be unique to the study, and it might be difficult to rely solely on a library / pre-defined set of questions for this module.
CRF is generally not a single form, rather a series of forms that record data pertinent to the trial. Some examples of the forms that might be included in the CRF are given below. However, this list is not exhaustive and should be customised according to the trial:
- Documentation of informed consent
- Screening or Eligibility form [inclusion and exclusion criteria]
- Randomization form
- Enrolment form
- Demographic information form
- Medical history form
- Physical or general examination form
- Concomitant medications form
- Baseline assessment or vital signs form
- Pre-existing and Adverse Events form
- Serious Adverse Events form
- Study visit forms
- End of study form
Essential elements of a well-designed CRF are explained in this document.
Electronic CRF (eCRF):
The eCRF is an auditable, electronic record of information that is reported for each participant in a trial. It enables clinical investigational data to be systematically captured, reviewed, stored, analysed and reported. eCRF’s are generally preferred over paper-based CRFs due to an improved data quality and integrity, relatively better discrepancy management and a faster data lock. eCRF’s also facilitate remote monitoring and a real time access to the data. It is however essential to ensure that the equipment (computers / mobile / tablets) used for data entry is password protected and can be accessed only by the appointed personnel. This is recommended to ensure privacy and confidentiality of research participants.
References and Further Reading:
- Good Clinical Practices for Clinical Research in India, Central Drugs Standard Control Organization, 2001, available online.
- ICH Harmonised Guideline, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), current step 4 version, dated 9th November 2016, available online (last accessed on 26.02.2019).
- Guidance for Industry: Electronic Source Data in Clinical Investigations, U.S. Department of Health and Human Services, Food and Drug Administration, September 2013, available online (last accessed 06.03.2019).