9.5 Each participant in a research will be requested to complete a comment and suggestion form so that any issues experienced by the subject can be addressed in a timely manner and improvements to the program can be achieved. 9.6 The form includes a provision to specifically address any safety concerns that the subject may have. It is essential that these concerns be addressed by the CRC staff as soon as they are made aware of them. The CRC Manager is to be notified and associated study staff included in addressing the concern. 9.7 All subject complaints or concerns and the actions taken to address them are reported to the CRQAC at the next meeting and to CORIHS if deemed necessary by the CRQAC or the PI. 10. Record Confidentiality All CRC Subject Records are deemed confidential and, as a result, access to such records is restricted. 10.1 The following individuals associated with the CRC may access a CRC Subject Record: The Principal Investigator The Responsible Physician The Participating Physician The Registered Nurse and/or other Non-licensed Technical staff assigned to the clinical study by the PI The CRC Head; The CRC Manager, The CRC Supervisor; The CRC Receptionist The Clinical Protocol Coordinator The Compliance Monitor, in the course of performing the records monitoring function. 10.2 In addition, the following individuals may access the subject record, under supervision of the CRC Supervisor or his/her delegate: A properly authorized representative of the sponsor (funding) organization; The individual named by the CRC Subject Record. This same individual may request a copy of his/her medical records upon (1) execution of an Authorization for Release of Clinical Information (CRC Core Form C007) and (2) submission of proper identification. The next of kin of the individual by the CRC Subject Record upon presentation of (1) proper evidence that the subject is deceased or otherwise unable to provide release authorization and (2) proper identification as next of kin. This same individual may obtain a copy of the medical record upon (1) providing a signed written request, (2) proper evidence indicating that the subject is deceased or otherwise unable to provide release authorization and (3) proper identification.
9.5 Each participant in a research will be requested to complete a comment and suggestion form so that any issues experienced by the subject can be addressed in a timely manner and improvements to the program can be achieved. 9.6 The form includes a provision to specifically address any safety concerns that the subject may have. It is essential that these concerns be addressed by the CRC staff as soon as they are made aware of them. The CRC Manager is to be notified and associated study staff included in addressing the concern. 9.7 All subject complaints or concerns and the actions taken to address them are reported to the CRQAC at the next meeting and to CORIHS if deemed necessary by the CRQAC or the PI. 10. Record Confidentiality All CRC Subject Records are deemed confidential and, as a result, access to such records is restricted. 10.1 The following individuals associated with the CRC may access a CRC Subject Record: The Principal Investigator The Responsible Physician The Participating Physician The Registered Nurse and/or other Non-licensed Technical staff assigned to the clinical study by the PI The CRC Head; The CRC Manager, The CRC Supervisor; The CRC Receptionist The Clinical Protocol Coordinator The Compliance Monitor, in the course of performing the records monitoring function. 10.2 In addition, the following individuals may access the subject record, under supervision of the CRC Supervisor or his/her delegate: A properly authorized representative of the sponsor (funding) organization; The individual named by the CRC Subject Record. This same individual may request a copy of his/her medical records upon (1) execution of an Authorization for Release of Clinical Information (CRC Core Form C007) and (2) submission of proper identification. The next of kin of the individual by the CRC Subject Record upon presentation of (1) proper evidence that the subject is deceased or otherwise unable to provide release authorization and (2) proper identification as next of kin. This same individual may obtain a copy of the medical record upon (1) providing a signed written request, (2) proper evidence indicating that the subject is deceased or otherwise unable to provide release authorization and (3) proper identification.
crc%20procedure%20manual.docx