Case Report Form
Encyclopedia
A Case Report Form is a paper or electronic questionnaire specifically used in clinical trial research. The Case Report Form is the tool used by the sponsor of the clinical trial
to collect data from each participating site. All data on each patient participating in a clinical trial are held and/or documented in the CRF, including adverse events
.
The sponsor of the clinical trial develops the CRF to collect the specific data they need in order to test
their hypotheses or answer their research questions. The size of a CRF can range from a handwritten one-time 'snapshot' of a patient's physical condition to hundreds of pages of electronically captured data obtained over a period of weeks or months. (It can also include required check-up visits months after the patient's treatment has stopped.)
The sponsor is responsible for designing a CRF that accurately represents the protocol of the clinical trial, as well as managing its production, monitoring the data collection and auditing the content of the filled-in CRFs.
Case report forms contain data obtained during the patient's participation in the clinical trial. Before being sent to the sponsor, this data is usually de-identified (not traceable to the patient) by removing the patient's name, medical record number, etc., and giving the patient a unique study number. The supervising Institutional Review Board
(IRB) oversees the release of any personally identifiable data to the sponsor.
From the sponsor's point of view, the main logistic goal of a clinical trial is to obtain accurate CRFs. However, because of human and machine error, the data entered in CRFs is rarely completely accurate or entirely readable.
When the study administrators or automated mechanisms process the CRFs that were sent to the sponsor by local researchers, they make a note of queries. Queries are non-sensible or questionable data that must be explained. Examples of data that would lead to a query: a male patient being on female birth control medication or having had an abortion, or a 15-year old participant having had hip replacement surgery. Each query has to be resolved by the individual attention of a member of each local research team, as well as an individual in the study administration. To ensure quality control, these queries are usually addressed and resolved before the CRF data is included by the sponsor in the final clinical study report. Depending on variables relating to the nature of the study, (e.g., the health of the study population), the effectiveness of the study administrators in resolving these queries can significantly impact the cost of studies.
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
to collect data from each participating site. All data on each patient participating in a clinical trial are held and/or documented in the CRF, including adverse events
Adverse event
An adverse event is any adverse change in health or side effect that occurs in a person who participates in a clinical trial while the patient is receiving the treatment or within a previously specified period of time after the treatment has been completed.AEs in patients participating in...
.
The sponsor of the clinical trial develops the CRF to collect the specific data they need in order to test
Statistics
Statistics is the study of the collection, organization, analysis, and interpretation of data. It deals with all aspects of this, including the planning of data collection in terms of the design of surveys and experiments....
their hypotheses or answer their research questions. The size of a CRF can range from a handwritten one-time 'snapshot' of a patient's physical condition to hundreds of pages of electronically captured data obtained over a period of weeks or months. (It can also include required check-up visits months after the patient's treatment has stopped.)
The sponsor is responsible for designing a CRF that accurately represents the protocol of the clinical trial, as well as managing its production, monitoring the data collection and auditing the content of the filled-in CRFs.
Case report forms contain data obtained during the patient's participation in the clinical trial. Before being sent to the sponsor, this data is usually de-identified (not traceable to the patient) by removing the patient's name, medical record number, etc., and giving the patient a unique study number. The supervising Institutional Review Board
Institutional review board
An institutional review board , also known as an independent ethics committee or ethical review board , is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the...
(IRB) oversees the release of any personally identifiable data to the sponsor.
From the sponsor's point of view, the main logistic goal of a clinical trial is to obtain accurate CRFs. However, because of human and machine error, the data entered in CRFs is rarely completely accurate or entirely readable.
When the study administrators or automated mechanisms process the CRFs that were sent to the sponsor by local researchers, they make a note of queries. Queries are non-sensible or questionable data that must be explained. Examples of data that would lead to a query: a male patient being on female birth control medication or having had an abortion, or a 15-year old participant having had hip replacement surgery. Each query has to be resolved by the individual attention of a member of each local research team, as well as an individual in the study administration. To ensure quality control, these queries are usually addressed and resolved before the CRF data is included by the sponsor in the final clinical study report. Depending on variables relating to the nature of the study, (e.g., the health of the study population), the effectiveness of the study administrators in resolving these queries can significantly impact the cost of studies.
See also
- Clinical trialClinical trialClinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
- Clinical trial protocolClinical trial protocolA clinical trial protocol is a document that describes the objective, design, methodology, statistical considerations, and organization of a clinical trial...
- Patient-reported outcomePatient-reported outcomeA patient-reported outcome or PRO is a questionnaire used in a clinical trial or a clinical setting, where the responses are collected directly from the patient.-Overview:...
- Patient DiaryPatient diaryA Patient Diary is a tool used during a clinical trial or a disease treatment to assess the patient's condition or to measure treatment compliance...
- Data clarification formData clarification formA Data Clarification Form or Data Query Form is a questionnaire specifically used in clinical research. The DCF is the primary data clarification tool from the trial sponsor or Contract Research Organization towards the investigator to clarify discrepancies and ask the investigator for...
- Clinical data acquisitionClinical data acquisitionAcquisition 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,...
- Electronic Data CaptureElectronic Data CaptureAn Electronic Data Capture system is a computerized system designedfor the collection of clinical data in electronic format for use mainly in human clinical trials.Typically, EDC systems provide:* a graphical user interface component for data entry...
- Clinical research associateClinical research associateA clinical research associate is a profession defined by Good clinical practice guidelines .The main function of a clinical research associate is to monitor clinical trials. He or she may work directly with the sponsor company of a clinical trial, as an independent freelancer or for a Contract...
(CRA) - Drug developmentDrug developmentDrug development is a blanket term used to define the process of bringing a new drug to the market once a lead compound has been identified through the process of drug discovery...
- SmartPen - technological system for digitally encoding and transmitting CRFs
- Web-DQS - Web-based Data Query System for resolving CRF queries
- Phoenix Software International - case report form software developers
External links
- International Clinical Sciences Support Center (ICSSC) CRF Development
- Standardized Case Report Form (CRF) Work Group - National Cancer InstituteNational Cancer InstituteThe National Cancer Institute is part of the National Institutes of Health , which is one of 11 agencies that are part of the U.S. Department of Health and Human Services. The NCI coordinates the U.S...
- Standard Operating Procedure – Develop and Manage a Case Report Form links to CRF information (PDF)
- Clinical Trials Software - Case Report Forms