CPHS requires that investigators wishing to continue approval for an already approved study complete a continuing review form (see below). In order to meet federal regulations, the CPHS continuing review form now requires investigators to provide a protocol summary and a status report on the progress of the research, including:

• The number of subjects accrued;
• A summary of adverse events and any unanticipated problems involving risks to subjects or others and any withdrawal of subjects from the research or complaints about the research since the last IRB review;
• A summary of any relevant recent literature, interim findings, and amendments or modifications to the research since the last review;
• Any relevant multi-center trial reports;
• Any other relevant information, especially information about risks associated with the research; and
• A copy of the current informed consent document and any newly proposed consent document.

Log into the iRIS system to view and fill out the CPHS continuing review form. Please note that the form must be customized per a specific protocol.

The principal investigator should receive an e-mail reminder via the iRIS system at least two months prior to the expiration date of their currently approved protocol. It is the responsibility of the investigator to complete continuing review form via the iRIS system.

Please note that regardless of your decision to continue or to terminate your protocol at the time of continuing review, either a termi form or the CR form must be completed in the iRIS system.

If you choose to terminate your protocol or if subject enrollment is completed at this time, then you do not need to include copies of the informed consent forms.

We have also instituted the use of an adverse event log (AE) which should be maintained by the investigator and submitted annually with the Continuing Review form. A copy of the AE Log will be attached to the Continuing Review forms in the future. For every AE reported to CPHS, please utilize only one entry or line on the AE log.

Protocol Closure or Termination

If you wish to close or terminate a currently approved research protocol, you MUST submit a closure notice using the appropriate CPHS form found in iRIS . The following information must be included in the form:

• Reason for closure or termination
• Brief summary of results or findings
• Total number of subjects enrolled in study
• Total number of adverse events occurring during study
• Other relevant information (such as DSMB reports

If you have any questions, please call the CPHS office at 713-500-7942.