Clinical trials case report forms

The following points are worthy of note in terms of the placement of data. In the case of studies with multiple objectives, reports should be placed in the section corresponding to their primary purpose. Reports of laboratory studies conducted with human materials to investigate pharmacokinetic effects should be placed in Section 5.3.2 of the clinical module, as opposed to the non-clinical module. A US submission requires that the individual case report forms of all trial subjects that died or were dropped from a study due to adverse events are included in Section 5.3.7. 

Thompson GS, Quan K, DuChene A. Case report form image management system for large multicenter clinical trials. Controlled Clin Trials 2001 P34. 

This chapter describes the key clinical data preparation issues and the different classes of clinical data found in clinical trials. Each class of data brings with it a different set of challenges and special handling issues. Sample case report form (CRF) pages are provided with each type of data to aid you in visualizing what the data look like. The key data preparation issues presented are concepts that apply universally across the various classes of clinical trial data. 

Clinical research coordinators (CRCs) are the research personnel who assist with pahent visits, and perform study-related procedures that do not require a physician (phlebotomy, vital signs, adverse event, and concomitant medicahon discussions, etc.). CRCs provide the PI or physician with data required for interpretation, medical decisions (inclusion/exclusion, dosage adjustment, patient withdrawal, adverse event causality, etc.), and trial oversight. In addition, CRCs are usually responsible for transcribing source documentation (medical records, clinic notes, laboratory reports, etc.) into case report forms (CRF) supplied by the study sponsor. 

The case report form (CRF) should be unambiguous and simple to use. Its completion should minimise the need for text. CRFs should consist of three modules. One module is common for all trials (laboratory data, etc.), one is common for all trials in the clinical programme for a given compound and one is specific to the study in question. In this way, data handlers become familiar with the forms and can therefore manage a larger number with fewer mistakes. A mechanism should be in existence to ensure that the clinician completes the CRF adequately. 

Case report forms (CRFs) are used throughout clinical trials to record data collected during a trial. They record all of the information specified in the protocol for each subject (all data recorded on the CRF must be verifiable from original source documentation). While the traditional paper CRF format is still used, electronic data collection is becoming more common. Voorhees and Scheipeter (2005) discussed CRF development in detail, highlighting some of the fundamental aspects of their purpose, design, and nature ... 

The case report form is the vital record of a clinical trial. It is necessary to design the CRF to collect all the data required by the protocol. Carefully designed CRFs are essential for the following reasons ... 

Many patients in clinical trials will be using complementary therapies (and we often omit to ask on the case report form)... 

The PI is responsible for maintaining records associated with the clinical study. These include case histories designed to record all observations or other pertinent data on each enrolled subject, independent of whether the subject received active treatment. Data for each trial subject is normally recorded on a case report form provided by the sponsor. The sponsor may also require study data to be recorded in a source document (patient chart). It is the responsibility of the PI to assure that the forms are filled out with the correct information and according to guidelines established by the sponsor. 

Because the chief investigator had to play a leading role in the clinical trial, the person appointed by the sponsor was usually a physician or professor who was an authority on the subject of the clinical trial. In practice, however, such people were generally too busy to perform the duties mentioned here, and the sponsor wrote a draft protocol and a draft of the explanatory note used when obtaining informed consent from subjects. In addition, the sponsor s monitor conveyed data and information to the physician in charge, as well as collecting and checking the case report forms (CRFs). 

Study personnel who interact with participants ate trained to capture the essence of any self-reported AEs on a case report form (CRF), one of the most important documents in clinical trials. Examples of reported AEs include "shortness of breath," "rash on left wrist," "dry mouth," and "vomiting." In addition to the description of the nature of the AE, additional information such as the following is typically collected ... 

This is a complete copy of an application submission and is intended to serve as a reference source for FDA reviewers to locate information not contained in the section of the review copy assigned to them. It serves as a reference source for other FDA officials, and as the repository of the copies of tabulations and clinical trial case report forms. 

Source documents are composed of hospital records, office charts, laboratory data sheets, subject diaries, pharmacy dispensing records, recorded data from automated instruments, x-rays, etc. Source documents should be legible and should document that the subject is participating in a clinical trial. Some of the key areas to cross reference source documents to case report forms and regulatory criteria are the informed consent process, inclusion/exclusion criteria, adverse experiences, investigational product administration, concomitant medications administered to the subject during the trial, withdrawal from the study for any reason, and subjects lost to follow-up. 

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