X. TERMINATION OF A PROTOCOL
A protocol is regarded as terminated when subject enrollment and subject follow-up are discontinued. A protocol may be terminated in any one of the following ways:
After receiving the approved termination application or request, the PCSC staff removes the protocol number, protocol record, protocol abstract, and protocol consent and assent documents from the MIS, the PROTRAK data base, and the World Wide Web. The PI is responsible for assigning patients to inactive status in the MIS or placing them on another active protocol. The PCSC staff retains the original NIH-1195-1 form or the termination memorandum and sends copies to the PI, PC, and the RSC (if applicable). A PCSC staff member's signature on the NIH-1195-1 form or termination memorandum completes the termination of the protocol.
When terminating a protocol, an important responsibility of the PI is properly informing subjects. Patients who have been in a masked (blinded) study should be told what treatment they have received. If possible, each participant should be given a synopsis of the outcome of the protocol and its potential meaning for the future.
Most important, the participants must understand poststudy arrangements. Where will they be followed? If at the CC, does that include all of their medical problems or only those that are "study related"? If follow-up is not at the CC, to whom should their records be sent? The "Physician to Receive Reports" listed on the admission record receives copies of discharge summaries from inpatient admissions, but no outpatient information goes out automatically. Thus, research participants must complete form NIH-527, "Authorization for the Release of Medical Information," (figure 15) if they wish to have information sent to anyone other than the "Physician to Receive Reports" listed on the admission record. The completed NIH-527 form should be forwarded to the Medicolegal Section of the Medical Record Department.
The overall objective is to ensure that those responsible for the patient's well-being are thoroughly, accurately, and promptly informed. This can be done in writing or by telephone; any such calls should be briefly described in the progress notes of the patient's medical record.
The PI should forward all records and documents pertaining to the care of a patient at the CC to the Medical Record Department for placement in the patient's permanent medical record. The PI should retain all research records and documents pertaining to the protocol for at least 3 years after the protocol is terminated, as called for by the MPA.
Phone: +7 (499) 394 63 00
|medical translation | medical translator | russian translation services | medical translation services | english to russian translating services | pharmaceutical translation|