Ethics Committee

ETHICS COMMITTEE OPERATIONS AND FUNCTIONS OPERATIONS Maintain SOP on all procedures Maintain written records Schedule the meetings Communication with the investigators Review process Standard operating procedures Written detailed instructions to ensure uniform performance of the function. Record keeping SOPs and Guidelines Membership document list,qualifications,copy of appointment letters,CVs Minutes of the meeting Study files for each IRB protocol number Conflict of interest statements Compliance assurance from IRB to the sponsor Scheduling of the meetings Fixed date and time of the meetings. Reschedule if the quorum is incomplete Communication with the Investigator INVESTIGATOR—EC Protocol deviation ADR reporting EC-INVESTIGATOR DECISION ON THE PROTOCOL ASSUNANCE OF COMPLIANCE TO GCP GUIDELINES The review process 1. THE DOCUMENTS reviewed  The application form for approval  DCGI approval for a NCE  The Protocol and CRFs  Details of preclinical work  Informed consent  Investigators brochure  Patient Information sheet  Recruitment materials, Any other

2. CATEGORIES OF ACTION TAKEN Approved in the form it is submitted Approved pending revisions Approved pending revisions and rereview by reviewers Disapproved 3. NEW PROTOCOL SUBMISSION Full board review Expedited review Full board review Involves greater than minimal risk IRB with quorum meets to approve the process May involve a primary and a secondary reviewer Expedited review Minimal risk: harm done by the intervention is no greater than those encountered in the daily life or during the performance of routine psychological or physical examination or test Conducted by the head of the institution and the Chair person E.g.Clinical studies of drugs and medical devices where IND application is not required,approved for marketting Collection of specimens by non invasive methods Collection of data from case records Research on group characteristics and behaviour 4. TIME FOR APPROVAL Varies from country to country Normally 1-3 months 5. AMENDMENTS Changes to subject selection methods,the addition of more subjects, a major procedural change in the protocol, increasing or decreasing dosages, leaving out or adding additional tests, a change in the PI, Co- Investigator; or other Authorized Study Personnel Federal regulations Insist that such changes need to be approved and reviewed by the IRB before implementation except when it is necessary to eliminate immediate hazards to the patient

Continuing review At intervals appropriate to the risk of human subjects At least once in a year Protocol deviation No deviations to be initiated without prior approval by the IRB Exceptions CHANGE DUE TO SAFETY REQUIREMENT INFORM WITHIN 3 DAYS ADMINISTRATIVE CHANGE: TO BE INFORMED ONLY Adverse events Prompt reporting by the investigator of any unexpected problem involving risks to others Adverse drug reaction to drugs,medical devices or any other study procedures DISABILITY - a substantial disruption of a person's ability to conduct normal life and functions. LIFE-THREATENING ADVERSE EXPERIENCE - any adverse experience that places the patient or subject at immediate risk of death. SERIOUS ADVERSE EVENT - any adverse experience that results in any of the following outcomes: death, a life-threatening adverse experience, inpatient hospitalization results in congenital anomaly UNANTICIPATED ADVERSE EVENT - any adverse experience, the nature, severity, or frequency of which is not consistent with the current investigator's brochure, risk information described in the investigational plan, or consent form. EXPECTED ADVERSE EVENT- any adverse experience, the nature, severity or frequency of which is consistent with the current investigator's brochure, risk information described in the general investigational plan, or consent form Categories required for submission If the serious adverse event is expected as indicated by the applicable product information, it MUST be listed as a risk in the “Risks” section of the Informed Consent. Adverse events If an Expected Serious Adverse Event occurs multiple times and is of a serious nature, a re-evaluation of the overall risk/benefit ratio of the research protocol may be necessary. Unexpected Serious Adverse Event considered medically important that is not consistent with the current investigator's brochure, risk information described in the general investigational plan, or consent form MUST be submitted to the IRB office.

EXPECTED NON-SERIOUS ADVERSE EVENT is not considered medically

important that is consistent with the current investigator's brochure, risk information described in the general investigational plan, or consent form. MUST be listed as a risk in the “Risks” section of the Informed Consent. An Expected Non-Serious Adverse Event DOES NOT need to be submitted toIRB Unexpected Non-Serious Adverse Event is not considered medically important that is not consistent with the current investigator's brochure, risk information described in the general investigational plan, or consent form. An Unexpected Non-Serious Adverse Event that is Definitely or Probably related MUST be submitted to the IRB office. Each event must be reviewed to determine if it has a relationship to the research and whether or not it could be an untoward effect of the drug, device or a research intervention. Reporting to the FDA and/or the Sponsor It is the responsibility of all investigators to report Serious Adverse Events (SAEs) to the sponsor (as described in the protocol) and/or the FDA. Such reports must be made in a timely manner. These reports are generally different from the reports to the IRB. www.fda.gov/oc/gcp/contactogcp.html.