QRTI Newsline --- Wednesday September 8, 2010

Documenting the Medical History to Protect Investigators and Subjects

By Rochelle L. Goodson

Both Clinical Investigators and subjects are at risk when a complete medical history is not obtained prior to entry in a clinical trial.Since subject safety is foremost in clinical research, the value of the history is just good clinical practice. Clinical Investigators that offer their own private patients the opportunity to enroll in a clinical trial often have a significant benefit over their research colleagues, i.e., a readily available and documented medical and medication history. This capability can often reduce the number of selection criteria errors and the investigator's potential liability. It also reduces the number of protocol violations reported by investigators and adverse reactions experienced by study subjects. The dual benefit of an adequate subject case history cannot be understated but what about study subjects screened for a clinical trial by investigators that do not have this information readily available?

Although obtaining the medical history may be a time-consuming and challenging task, it must be a priority for all researchers. Minimizing the importance of this effort presents challenges to monitors and auditors ranging from verification of eligibility to determining safety risks incurred when a poor medical history is evident.

Obtaining Medical History Records

In a circumstance when the subject is screening for a trial in which the investigator is not their primary care provider (PCP), the following steps can ensure that medical assessments are optimal and complete:

• Obtain a signed and dated Medical Record Release Form from the subject
• At minimum, request a clinical summary and pertinent lab or diagnostic results
• Request supporting clinical documents specific to a protocol, e.g., consultation report, mammography report, ophthalmologic examination
• Conduct an oral interview with the subject

Obtaining a Medical History in the Absence of Records

In a circumstance when the subject is responding to an advertisement and does not have a PCP and/or previous medical records are unavailable, there are additional efforts that may be helpful. The following steps to obtain a medical history permit the assessment of a potential clinical research subject to ensure their suitability and safety, prior to enrollment:

• Ask the subject to complete a medical history questionnaire that lists major body systems and/or related conditions that have been diagnosed
• Review the document completed by the subject and obtain necessary clarifications
• Interview the subject regarding medical and medication history
• Document the medical history using a standard form that captures medical conditions, diagnosis(es), surgeries, allergies, medications, including questions that may be pertinent to the current trial
• Request subjects to sign and date the medical history they provide

Additional Considerations

In addition to the logistical attempts made to obtain medical history records or information necessary to ascertain a subject's eligibility for a trial, it is also important to determine the qualifications of the interviewer. Study staff often includes research coordinators or assistants who do not have the appropriate clinical training, education or qualification to perform an intake interview. It is the Principal Investigator's responsibility to ensure that the staff conducting medical history interviews has the clinical knowledge base and training that permit them to ask the right questions, seek clarifications or additional information, when indicated.

It is also important to encourage good source documentation of the actual process of obtaining a medical history. A progress note or a signed and dated history form offers evidence that this activity transpired and that the Clinical Investigator reviewed the history prior to enrolling a study subject in a clinical trial. These efforts ensure proper subject screening and protect both the subject and the Clinical Investigator.

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