Case report forms

All protocol-required data are recorded at the trial site on Case Report Forms (CRFs), which may be in either electronic or hard-copy format. Data for individual subjects are recorded on separate CRFs. The CRFs are used to transfer trial data to the sponsor for analysis and evaluation. 

Signed protocol and amendments, if any and sample Case Report Form (CRF)... 

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. 

Case Report Forms and Individual Patient Listings. 5.4 Literature References... 

The investigator s brochure, the case report forms, the confirmation of insurance of subjects and the documents used to obtain informed consent... 

Multiple options for data input, the most important of which are machine read and thus obviate the bottleneck that often occurs in data entry. The two main options are Optical Mark Read (bubble) forms, and Smart-Pen , a special pen with an optical sensor that records each keystroke (Fig. 23.2). Both utilize paper case report forms, for which sites have indicated a strong preference over the requirement to enter data on a keyboard. 

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. 

The final meddra data set in this program contains the lower-level term code (llt code) that can then be merged with the adverse events or medical conditions database. By merging the MedDRA dictionary data with the disease data, you can match the verbatim event text captured on the case report form with the preferred term and associated body system. Then you can summarize these data by body system and preferred term you will see an example of this in Chapter 5. 

The data set in this program can then be merged with the medications data from the case report form by the drugrecno variable to attach the preferred term from the WHODrug dictionary with the verbatim drug name collected from the case report form. 

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. 

We need additional progress on data standardization, including case-report forms. This effort has moved forward in the past several years through the work of fhe Clinical Data... 

Inclusion and exclusion criteria Case report form... 

All the information relating to a subject is recorded in the Case Report Form. The commencement of the trial will include gathering baseline data from the... 

CASE REPORT FORM Personal Data Patient s Last name First name Middle initiaLs ... 

An important aspect of the trial is the meticulous monitoring required. This is a process to interact with the subjects monitoring their well-being, the effects of drug and placebo, adverse events, and so on. Information is recorded on the Case Report Forms. All the processes are recorded in accordance with Standard Operating Procedures, which describe how the trial is to be conducted, and GCP. 

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