Case Report Form

A Case Report Form (CRF) is a printed, optical or electronic questionnaire-document sheets, designed for recording of all the protocol mentioned information, which is required to be reported to the sponsor for each trial participants, specifically used in clinical trial research. The Case Report Form is a part of clinical data management, a data collection tool and is used by sponsor to collect the clinical trial data at each clinical trial site. The case report form collects all data relevent to each participating patient in a clinical trial, including adverse events,

The sponsor designs and develops the CRF to collect clinical trial specific data needed to support their hypotheses or to answer their research questions. The size of the CRF vary and it will depend on the clinical trial treatment periods, follow up periods, treatment cycles and data needed to assure the effectiveness and safety of the investigational drug.

The Case record form is used for several purposes:

1. to ensure data collection in accordance with the Study protocol;
2. to ensure fulfilling of the regulatory authorities' requirements for data collection;
3. to facilitate the effective, comprehensive data processing and analysis, results reporting, and to promote the safety data sharing between the study team and other departments of the institution.

The data collected in the study site during the course of a study should be comprehensive and provide true and fair information on what happened to each study subject. Only if the above criteria are met, the study will reliably answer the questions concerning the efficacy and safety of the investigational drug.

The purpose of a CRF is to ensure efficient and complete data collection in accordance with the protocol. This facilitates analysis and clear reporting of the data and finally, the outcome determines efficacy and safety of a product. If you think about why sponsors design studies, it is obviously to gather information on efficacy and safety. Since the CRF is the primary vehicle for collecting this data, it is a very critical and important part of the study process.

The sponsor is solely responsible for designing, developing and production of the CRF which accurately comply and collect data as required by the clinical trial protocol, also monitoring and auditing of the data collection and the content of the filled-in CRFs.

The conent of the case repport form includes the two part of the as below mwntioned :

• The Generic Case Report Form Completion Guidelines
• CRF complition guidelines

All CRF's should include the following data:

• study title and number;
• Investigator's name;
• study subject/patient ID (number and initials);
• inclusion / exclusion criteria;
• demographic data;
• detailed description of dosage regimens of investigational drug;
• concomitant treatment;
• adverse events (side effects and intercurrent diseases);
• conclusion on subject's health;
• Investigator's signature and date.

Additionally, the CRF's should include special pages to record the following information:

• past medical history;
• results of physical examination;
• primary and secondary diagnoses;
• relevant previous treatment;
• baseline characteristics, results of interim assessments, evaluation of efficacy endpoints, laboratory tests, description of study procedures etc.

All CRF's should be legible and suitable for duplication and possible additional sharing.

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.