Clinical trials documentation CRFs

The protocol should specify what should be recorded directly into the CRF and what will also be recorded in the medical records. The CRF will contain all the pertinent data associated specifically with the clinical trial but some will be repeated in the medical records, for example, the protocol identification number, date of consent, date of commencement of the study, key baseline medical findings, visit dates, start and finish dates of the study drug/placebo or treatment, concurrent medication, adverse events and key efficacy and any unscheduled or scheduled actions or interventions (such as escape medication). Additional information obtained from biopsy reports, radiographs and similar documents will provide confirmation that the data in the CRF are recorded correctly. Monitors, QA auditors and inspectors need to see all the medical records available to the investigator. It is not appropriate to create copies of data from CRFs or checklists derived from medical records and claim that these are source documents. 

The clinical trial monitor is a temporary member of the site team. A good monitor will conduct scheduled visits, and the investigator and the site staff should provide sufficient time to answer questions and correct data in the CRF that has been transferred incorrectly from source documents. Common errors are omitting negative answers and signatures. The monitor will need space to work and should be provided with requested documentation, including medical records, for review. 

The closing down of the clinical trial at the site after the last visit of the last study subject has finished and all the CRFs are completed is an important part of the clinical trial. The process of archiving the documentation, both at the site and at the sponsor office, needs to take place -ideally as soon as possible after the end of the clinical phase of the study. The effort required to do this well is very much less than that which will be required if deficiencies are identified later -particularly if that occurs during a regulatory authority inspection ... 

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 ... 

This term is generally used to denote the administration file kept for each trial and each investigation centre. Box 6.4 lists some of the documents that need to be present before a clinical trial starts. (See ICH GCP Chapter 8 for the full list.) Once the study has started, other documents will be added, including completed CRFs, ICFs and subjects medical records, and other documents directly involved in the study. Some documents have to be kept specifically at the sponsor s office or the controlling centre. Separate files will contain financial and budget-related documents. Some of the documents listed in Box 6.4 are discussed more fully below. 

Many investigator sites employ part- or full-time nurses to support the clinical trials. Nurses should never be considered to be an extravagance, because without them, the onus of administration and QC is solely on the investigator. The clinical trial nurse can help the investigator in many ways, but two of the most important are ensuring that the CRF reflects what is present in the source documents, such as essential events of the medical history of the subject, and close liaison with the sponsor s monitor. 

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 ... 

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. 

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