Next to a well-constructed research question, the case report form (CRF) or the eCRF, its electronic equivalent, is the most important consideration. If this is flawed or proven to be biased in any manner, the credibility of the clinical study becomes questionable.
What Are CRF or eCRF?
The CRF and eCRF are records of all significant patient and protocol-required information during the clinical study. The sponsor requires these to determine how safe and effective the drugs are under trial which will later benefit the provision of health care.
Printed or paper-based CRF are still in use, but eCRFs are gaining traction because of the following advantages:
- Collect data completely
- Process and analyze data accurately
- Readily track discrepancies
- Quickly search database
- Share standardized data
- Securely and safely lock information from those not included in the trial
- Easily get approval from compliance bodies
Each detail of the CRF system is meticulously studied and must comply with the clinical trial protocol approved by the Food and Drug Administration (FDA). Accuracy of recorded information–-its correctness, completeness, and timeliness–-must be intact at all times.
What Information Is Included in a CRF or eCRF?
Ideally, the forms must include instructions on how to complete them. The wording should be clear and can be answered by ticking the box of choice whenever possible. It should include the version or modification, subject signature with date, and investigator signature with date.
The CRF or eCRF have three parts: the header, safety-, and efficacy-related section. The CRF or eCRF must include the following information.
The header contains the information that identifies the study:
- Protocol ID and visits
- Version number
- Site Code
- Subject identification number
- Case number
The safety-related section includes the following:
- Patient information (name, gender, date of birth, medical/surgical history, physical examination/vital signs, current medications)
- Demographics (age and ethnicity)
- Adverse effects
- Deaths
- Drop-outs and reasons
- Eligibility criteria
The efficacy-related section includes the following:
- Protocol which determines the data for inclusion
- Definition of pre-clinical study measurements
- Definition of measurement of effects or lesions (e.g., diameter, volume, shape)
- Efficacy definition or endpoints
- Other checks capable of measuring the efficacy
Information collected from the study is sacred and must not be manipulated. The CRF design must be able to:
- Standardize recorded data
- Comply with the research protocol
- Select unbiased trial groups
- Collect the data efficiently and without delay
- Apply statistical analysis to collected data
- Measure efficacy
- Determine safety levels for different groups (e.g. ageing population)
The above are the kinds of information you’d find in CRFs.
What Are The Considerations During CRF Development?
The guiding principles when designing a CRF are the integrity of data and the quality of information. The CRF design is determined by the protocol and must be able to meet the needs of the investigators, statisticians, and other personalities involved in the design.
The sample population must be sufficient so that the data can support the hypothesis. Collecting too much information may not be a good use of resources. It can also muddle up analysis. Concentrating on parameters that would be useful in the study is essential to limit the scope.
By doing this, finances are not wasted on collecting data that are neither relevant nor can be statistically analyzed for efficacy and safety. How data is processed and managed determines how useful it can be in the future.
While both CRF and eCRF have the same objectives, there are differences in how these two are developed. The CRF is prone to errors and duplications during the encoding and transfer of the data. The validity of CRF conclusions may be questioned if data collection isn’t impeccable.
Big sponsor companies prefer to use eCRFs because these
- Support the investigation of multiple aspects of a given test concern
- Automatically generate data with almost no data entry errors
- Capture data with ease and without duplication of each patient form
- Provide instant search resolution
- Enable accountability from signatories
That said, some drug companies are hesitant about accepting eCRFs because of the lack of technology, limited finances to shift to cloud services, the inadequate skill of investigators to design and capture electronic data, and the cost of software,
Poor Versus Good CRF Design
A poorly designed clinical trial requires numerous modifications along its course to completion and collects too much or too little data. Either way, it’s inefficient for resources and may be invalidated for lack of quality data. A well-designed CRF must:
- be user-friendly
- consistently capture valid data
- include an interdisciplinary review
Sign-offs should include a project team member tasked with the trial conduct, analysis, data-sharing, and reporting of the results. The investigator must check for the accuracy and completeness of the given information. All data must be timely, and the investigator must report any modifications or changes.
Summary
The protocol determines the data for analysis that should or should not be in the CRF or eCRF. Questions should be concise and systematically provide the complete data for safety and efficacy needed by the regulatory agencies.
