Identification and Reporting of Adverse Events

1.                   An SAE should be reported within 72 hours (the generic WHO SAE report form or a customized version of the same) can be used.

2.                   For clinical trials involving investigation products, a summary of the SAEs from local sites and other participating sites should be provided on a quarterly basis.

3.                   An SAE report must clearly show the steps/interventions that have been taken to address the same.

4.                   Report should be submitted in duplicate.

5.                   The SAE report must be endorsed by the Clinical Trial Monitor/Physician.

At the discretion of the KNH-ERRC, an ad hoc committee shall be formed to look into details of any issue and report to the main committee.  Non members shall be invited to give their expert opinion on the matter at hand.  The ad hoc committee shall be given two weeks to complete the report. The committee shall review the following:

1.       review of unanticipated problems

2.       serious or continuing noncompliance

3.       any suspension or termination of KNH-ERRC approval

4.       Reviewing of adverse events and decision making

Note:  Efforts shall be made to have the investigators attend an interview with ERRC members prior to the termination of the research.  The investigators might be asked to carry out training programs and provide specific materials for investigators, with specific directives included in approval letters to investigators on random audits of research records and consenting