Investigational Product Accountability Log in Cross Over Study - PDF by qdj93270

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									Robarts Clinical Imaging Research Laboratories




     STANDARD OPERATING PROCEDURE FOR
     ADVERSE EVENT AND SERIOUS ADVERSE
              EVENT REPORTING


SOP Number: GCP SM 404.02

                                                              Effective Date:
Version Number & Date: 2nd version; 17 June 2010              05 July 2010

Superseded Version Number & Date (if applicable):             Review Date:
1st version; 24 October 2005                                  05 July 2012




Revision
Chronology:

Version Number     Version Date       Reason for Change
404.01             24 October 2005    Initial Version
404.02             17 June 2010       Merge 404 and 405; Update and Review; compliance
                                      with Lawson SOPs




                 Printed Name        Signature              Date (dd/mmm/yyyy)

Written By:      Shayna McKay        ________________       ____/_____/_____

Reviewed By:     Sandra Halko        ________________       ____/_____/_____

Approved By:     Grace Parraga       ________________       ____/_____/_____



GCP 404.02                                                AE and SAE Reporting
Page 1 of 5                                                       17 June 2010
Robarts Clinical Imaging Research Laboratories


1. INTRODUCTION & PURPOSE

The rights, safety, and well-being of clinical trial participants are the most
important considerations in clinical trials, and should prevail over the interests of
science. Adverse event (AE) and serious adverse event (SAE) reporting enforces
this commitment to participant safety. Adverse events must be notes as per
protocol in the source documents and the case report forms (CRFs), their
significance must be assessed, and other information must be provided for
reporting AEs externally [i.e., to research ethics boards (REBs) and regulatory
authorities]. The sponsor and clinical research staff at the site must ensure that
all safety information is appropriately reported and documented.


2. SCOPE

This standard operating procedure (SOP) outlines the processes to be followed
for reporting AEs and SAEs to the study sponsor (if applicable), regulatory
authorities, and the University of Western Ontario Health Sciences REB (UWO
HSREB) as per Health Canada Regulations and UWO HSREB guidelines.


3. APPLICABLE REGULATIONS AND GUIDELINES

Health Canada Therapeutic Products Directorate Food and Drug Regulations for
    Clinical Trials
FDA Code of Federal Regulations, Title 21
International Conference on Harmonisation; Good Clinical Practice: Consolidated
    Guidelines
Tri-Council Policy Statement; Ethical Conduct for Research Involving Humans
The University of Western Ontario Health Sciences Research Ethics Board
    Guidelines


4. REFERENCES TO OTHER APPLICABLE SOPs

All SOPs are cross-referenced to this SOP.
This SOP refers to GCP SOP PM 305: Investigational Product Accountability
This SOP refers to GCP SOP PM 301: Ongoing HSREB Interactions


5. ATTACHMENTS

A. Local SAE Report Tracking Log




GCP 404.02                                                  AE and SAE Reporting
Page 2 of 5                                                         17 June 2010
Robarts Clinical Imaging Research Laboratories


6. RESPONSIBILITY

This SOP applies to all clinical personnel involved in conducting clinical trial
activities at this site.


7. DEFINITIONS

The following definitions apply to this SOP:

Adverse Event (AE): An adverse event is broadly defined as any unfavorable or
unintended sign (including an abnormal laboratory finding), symptom, or disease
temporally associated with the use of an investigational product, or participation
in the study whether or not considered related to participation in the research.

Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (SADR):
Any untoward medical occurrence that at any dose results in death, is life
threatening, requires inpatient hospitalisation or prolongation of existing
hospitalisation, results in persistent or significant disability or incapacity, or is a
congenital anomaly or birth defect or requires medical or surgical interventions to
prevent any of the above outcomes.


8. PROCESS OVERVIEW

A.   Preparation prior to study commencement
B.   Managing AEs and SAEs during study
C.   Safety reports
D.   HSREB reporting


9. PROCEDURES

A. Preparation Prior to Study Commencement

1. For sponsored studies, the sponsor will outline the procedures for reporting
   and recording AEs and SAEs in the protocol. All AEs and SAEs should be
   recorded on the Case Report Forms (CRFs) provided by the sponsor and in
   the source documents at the site.
2. International guidelines have resulted in the standardization of much of these
   reporting processes for the sponsor.
       a. Be aware of the reporting requirements of the local REB and
           regulatory authorities
       b. Ensure that all clinical staff are aware of participant safety reporting for
           AEs and SAEs.


GCP 404.02                                                    AE and SAE Reporting
Page 3 of 5                                                           17 June 2010
Robarts Clinical Imaging Research Laboratories


B. Managing AEs and SAEs During Study

1. Continue to educate participants about expected adverse events and the
    importance of reporting to the coordinator or investigator at clinical visits
    and/or during telephone contact.
2. At each clinic visit/telephone contact, document the details of any local AEs or
    SAEs.
3. Document local adverse events using the protocol-defined terminology [e.g.
    Medical Dictionary for Regulatory Activities (MedDRA)].
4. Grade the severity of the local AE using the protocol-defined criteria (i.e. mild,
    moderate or severe).
5. Assess and assign causality/attribution for any local AEs. The attribution or
    causality is the determination of whether an AE is related to the
    investigational treatment or procedure.
         a. There is currently no standard, international nomenclature
         b. The final assessment of the severity and causality must be made and
            signed-off by the QI or co-investigator
6. As per ICH guidelines AEs are defined as serious using the following criteria.
    If the event:
         a. Results in death
         b. Is life-threatening
         c. Requires inpatient hospitalization or prolongation of existing
            hospitalization
         d. Results in persistent or significant disability/incapacity (as per
            reporter’s opinion)
         e. Is a congenital anomaly/birth defect
         f. Other medically important condition
7. Report all local SAEs to the sponsor within 24 hours of being informed about
    the event, by telephone and/or fax, according to the sponsor’s specified
    reporting procedures and instructions. Follow up with additional information
    as soon as it becomes available.
8. For local SAEs, use the reporting methods provided by the sponsor to
    complete the required documentation for expedited reporting.
9. If the local AE or SAE results in breaking the randomization code, document
    and inform the sponsor and the monitor as to why the code was broken. Also
    refer to the SOP on Investigation Product Accountability for unblinding
    procedures.
         a. Where possible, maintain the blind for personnel responsible for
            analysis and interpretation of results at the study’s conclusion
10. Record all information about local AEs or SAEs in the CRFs as required and
    ensure that all of this information is available in the source documents.
    Information to be recorded should include:
         a. Date of onset
         b. Symptoms of the event, including frequency, severity, outcome
         c. Action taken, such as medications given, procedures performed, or
            discontinuation of study drug

GCP 404.02                                                  AE and SAE Reporting
Page 4 of 5                                                         17 June 2010
Robarts Clinical Imaging Research Laboratories


11. Follow up and report any ongoing local AEs or SAEs as required in the study
    protocol.
12. File copies of all communication with the sponsor regarding local AE or SAE
    reporting, including faxes, telephone calls, instructions given and follow up in
    the investigator study files.
13. Ensure that with any recording and reporting subject confidentiality and
    adherence to PHIPA are maintained.

C. Safety Reports

1. Use the UWO HSREB on-line reporting system to produce reports for tracking
   non-local or spontaneous reports.
       a. User name and password are available from the CRC
2. The QI must review safety reports received from the sponsor.
3. Submit safety reports/summaries and follow-up information to the HSREB,
   according to the HSREB policies.
4. File the study safety reports and associated HSREB correspondence in the
   study files.

D. HSREB Reporting

1. Report all SAEs to the HSREB according to local HSREB and regulatory
   requirements.
2. Submit all safety reports/summaries (such as IND Safety Updates, CIOMS,
   MedWatch reports) and follow-up information on an ongoing basis to the
   HSREB for acknowledgement or review, according to local HSREB
   requirements. Copies of the associated HSREB correspondence should be
   provided to the sponsor, according to the sponsor requirements.
3. Refer to the SOP on HSREB reporting procedures.




GCP 404.02                                                  AE and SAE Reporting
Page 5 of 5                                                         17 June 2010

								
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