IND Safety Report Submission SOP

Management of Safety Reports – COMIRB studies only

1. SCOPE

This SOP applies to all protocols reviewed and approved by COMIRB.

1. PURPOSE

The purpose of this SOP is to outline the process for review, submission, and retention of all IND safety reports received by the PI of a currently approved study.

1. BACKGROUND

All IND safety reports received by the PI must be reviewed, submitted and retained in a regulatory compliant and consistent format. This policy was written in order to facilitate this process.

1. ACCOUNTABILITY

1. The PI is responsible for:
2. Reviewing all safety reports received and determining if the event occurred on a study that is also being conducted at UCD or an affiliate.
3. Submitting and retaining all SRs received according to policy, as outlined in section VI of this policy

1. The Principle Investigator has the responsibility for reviewing all safety reports that involve an unanticipated event occurring on a study also being conducted at UCD or an affiliate for which he/she is the PI.

1. DEFINITIONS

1. Acronyms

PI – Principle Investigator

N/A – Not Applicable

SOP – Standard Operating Procedure

SR – Safety Report

MFR# - Manufacturer Number

COMIRB – Colorado Multiple Institutional Review Board

UCD AMC – University of ColoradoDenver Anschutz Medical Campus

UCD – University of ColoradoDenver

UCH – University of ColoradoHospital

VAMC – Veteran’s AffairsMedicalCenter

DHMC – DenverHealthMedicalCenter

CPC – ColoradoPreventionCenter

IB or IDB – Investigator’s Brochure or Investigational Drug Brochure

IND – Investigational New Drug

1. Definitions
2. UnanticipatedProblem Involving Risks to Participants or Others (Unanticipated Problem): Any event or information that was unforeseen and

indicates that the research procedures caused harm (including physical, psychological, economic, or social harm) to participants or others or indicates that participants or others are at increased risk of harm than was previously known or recognized.

1. Adverse Event: Any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure (attribution of unrelated, unlikely, possible, probable or definite).

1. Unanticipated event: Any adverse experience where the nature, severity or frequency is not identified in the investigational brochure, described in the application form or detailed in the consent form.

1. Possibly related: In the opinion of the PI, the adverse event is unlikely to be related to the study intervention, drug or device.

1. Probably related: In the opinion of the PI, there is a reasonable probability that the adverse event is related to the study intervention, drug or device.

1. Related to the research: An event is “related to the research procedures” if in the opinion of the principal investigator, it was more likely than not [probably] to be caused by the research procedures or if it is more likely that not [probably] that the event affects the rights and welfare of current participants.

1. Internal event / problem: An occurrence involving research subjects enrolled in a project approved by COMIRB and directed by a principal investigator employed by the University of Colorado at Denver Anschutz Medical Campus (or affiliate site) or one whose project is under the purview of the COMIRB).

1. External event / problem: An occurrence involving research subjects enrolled in multi-center research projects that do not fall under the purview of the COMIRB (i.e. sites other than UCD, UCH, VAMC, DHMC, CPC).

1. Prompt Reporting: Reportable events must be submitted to COMIRB within 5 working days of the event or knowledge of the event.

1. POLICY

This policy will be used by all Principal Investigators and their research team when reviewing, submitting, and retaining SRs received by UCD or affiliate PI. Note: All SRs do not need to be reported within 5 days even if it involves a death. Reporting is based on section VII and the appendixed flow diagram.

1. PROCEDURES
2. IND SR (for a drug or device) is received by the PI.
3. PI or research team receive SR via direct mail from sponsor or coordinating site.
4. PI or research team review SR and determine if the report relates to the approved study at UCD or affiliate.
5. Is UCD or affiliate is an external participating site? YES, then:
6. Is the event unrelated to the study treatment?
7. Yes. The report is filed in a protocol or drug specific binder and kept by the PI.

(i)An updated IB is submitted to COMIRB upon receipt

1. Is the event expected or unexpected and possibly related to the study treatment?
2. Yes. These reports are evaluated for increased frequency and/or severity (i.e. trends) by:

(i)Investigator’s Brochure

(ii)DSMB or safety officer

(iii)PI or research team

1. Are there increased frequency and/or severity concerns?

(i)Submit aggregate data report (from DSMB, IB) to COMIRB once available.

1. Is the event unexpected and probably/definitely related to the study treatment?
2. Yes. The report is submitted to COMIRB within 5 days of research team’s first knowledge of the report as an unanticipated problem.

(i)If the investigation involved a drug: relationship to event can be based on sponsor’s documentation

(ii)If the investigation involved a device: the PI or research team must determine relatedness/expectedness

1. Is UCD or affiliate an external participating site? NO, then:
2. The report is reviewed by the PI or research team to determine if this is significant new information. Yes, then:
3. The report is submitted to COMIRB within 5 days of research team’s first knowledge of the report as an unanticipated problem
4. The report is filed in a protocol or drug specific binder
5. All revised IBs will be submitted to COMIRB

1. APPROVAL

This section contains the signatures of the staff approving the SOP.

Alison LakinDate: 03.01.10

Director, COMIRB