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 OBJECTIVE 1: STUDY RECORD MAINTENANCE

This section describes the specific documents that are required in support of CTSU protocol activities.

Section topics include:
Regulatory Binder and Checklist: Contains all study-specific information and regulatory documentation.
Source Documentation and Guidelines: Contains the original records of patient information and all the information related to a patient's protocol treatment.
Case Report Form (CRF) Notebook: Contains patient information related only to the study.
Study Closeout: Identifies when study is officially closed and what happens following "closeout."
Record Retention: Describes regulations regarding retention of study records.
Clinical Laboratory Certification: Describes requirement of certification.

Module Objectives
1
 Identify specific regulatory documentation, medical records, and laboratory certification that must be maintained according to Federal regulations and Good Clinical Practice
2
 Describe the procedure for submission of data to the CTSU
3
 Implement the procedures to acquire study agents specific for a protocol on the CTSU menu
4
 Demonstrate the procedure for reporting adverse events for patients enrolled through the CTSU
5
 Summarize radiation therapy guidelines that will need to be initiated at the study site prior to enrolling patients on CTSU protocols where radiation therapy is a component of the treatment intervention
6
 Describe the rationale and process for auditing data obtained for patients enrolled on a CTSU protocol
7
 Explain CTSU Quality Assurance
Regulatory Binder and Checklist

The Regulatory Binder contains all study-specific information and regulatory documentation. The Binder does not include completed patient Case Report Forms or signed patient informed consent forms. The Study Binder, Investigator Binder, Administrative Binder, Regulatory Files, and Investigator's Study Files are terms used synonymously to describe the Regulatory Binder. The Regulatory Binder may take the form of file folders, a 3-ring binder, a filing system, or a combination of these organizational methods. The site may keep all original signed patient informed consents in the patient's medical record and not in the Regulatory Binder.

The Regulatory Binder typically contains the elements described in the Regulatory Binder Checklist. The order and organization of the documents may vary from site to site.

Click to view Essential Documents for the conduct of a clinical trial.

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Source Documentation and Guidelines

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Click for a List of Source Documents

Source documents are the original records of patient information (e.g., the medical chart) and contain all the information related to a patient's protocol treatment. Source documents are used to verify the accuracy of the study data, to confirm that the patient met the requirements for eligibility, and that procedures mandated in the protocol were followed. An Investigator is required to prepare and maintain adequate and accurate documentation that records all observations and other data pertinent to the investigation for each patient participating in the study. All data recorded in the research record must originate in source documents specific for the patient.
Source documents verify the information abstracted on Case Report Forms. All patient case records (flow sheets, clinical records, physician notes, correspondences, etc.) must adhere to the following standards:

Legible clear labeling in permanent ink
Patient's name, date of birth, or medical record number included on each page
Signed and dated in a real time basis by health care practitioner evaluating or treating the patient
Corrections made with a single line through the error, and then initialed and dated by the person making the correction
In addition, all laboratory reports, pathology reports, x-rays, and scans must have:
Complete identifying information (name and address of the laboratory performing, and analyzing and/or reporting the results of the test)

Range of normal values for each result listed
Case Report Form (CRF) Notebook

Case Report Forms (CRFs) are used to gather patient information specific for the study. Each patient has a Case Report Form Notebook (or another system to organize the CRFs). Some Cooperative Groups provide notebooks and a set of forms for each patient. CRFs for studies on the CTSU menu are found in the protocol-specific area of the web site.

If a CRF Notebook is used, it should be arranged in a protocol-specific logical order. The forms in each section may be arranged chronologically or in reverse chronological order. In either case, there must be consistency throughout the notebook.

Each CRF should identify the patient by his or her study/randomization/registration number, but should not contain complete patient identifying information (name, full date of birth, etc.). All entries should be dated and signed.

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Click for a Suggested List of CRF Notebook Sections
Study Closeout

Once the specified number of patients for the study are registered, the study is "closed to accrual" by the Cooperative Group. After the study closes to accrual, current patients continue to receive treatment according to the protocol. Patients are followed according to the followup instructions in the protocol (e.g., "for 5 years or until death").

The Cooperative Group officially closes the study after the last patient reaches the maximum followup point or dies. Alternatively, the Cooperative Group can close the study when followup data have been received, as defined in the protocol document.

Record Retention

The Department of Health and Human Services and the Food and Drug Administration have regulations related to retention of protocol records. The DHHS regulation (45 CFR 46.115) provides direction for all research conducted or supported by any Federal department or agency. This regulation states that IRB records relating to research conducted shall be retained for at least 3 years after completion of the research. The FDA regulation (21 CFR 56.115) is virtually identical; it also states that IRB records must be retained for at least 3 years after completion of the research.

Clinical Trials with a Food and Drug Administration (FDA) Investigational New Drug Application (IND) must additionally comply with 21 CFR 312.57 and 21 CFR 312.62. These regulations apply to investigational drug records, Investigator financial interest records, and patient case histories. Both regulations require that the sponsor retain records and reports for 2 years after a marketing application is approved for the drug. If an application is not approved for the drug, the sponsor retains records and reports until 2 years after shipment and delivery of the drug for investigational use is discontinued and the FDA has been so notified.

Guidance may be given for record retention by the lead Cooperative Group sponsoring the protocol on a per protocol basis. However, the guidance cannot be less stringent than Federal regulations.

Clinical Laboratory Certification

CTSU collection of Clinical Laboratory certification is a protocol-specific requirement for some Cooperative Group protocols. The College of American Pathologists (CAP) or the Clinical Laboratory Improvement Amendments Program (CLIA) through the Centers for Medicare and Medicaid Services (CMS) usually grants certification. CAP and CLIA establish quality standards for all laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed. Documentation of certification (if required) is filed in the regulatory files.

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