Modifications, Changes to Personnel, Safety Reporting, Annual/Final Reports

Modifications Submission Requirements

If you intend to modify your project you will be required to submit a modification request form. This can include, but is not limited to, changes to the following:

  • Recruitment, methodology and/or funding
  • Participant information statement and consent form/s (PISCF)
  • Advertisements
  • Approval period i.e. if your ethics approval is due to expire and you require an extension. 

How do I submit a modification request?

  1. Complete a Modification Request
  2. Attach tracked and clean copy of all updated documents 
  3. Submit the modification request via email to the HREC or HREA Panel that provided approval for your project
  4. Submit via email by 5pm on the closing date.

How do I make changes to the personnel listed on an approved project?

To add or remove an investigator, co-investigator or student from your project you will be required to submit a personnel modification request. This can be done by following the below steps:

  1. Complete a Personnel Modification
  2. Attach your completed Personnel Modification to an email
  3. In the cc section of the email, copy in any named investigators listed on the modification form.
  4. Submit via email by 5pm on the closing date.

 

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Safety Monitoring Reporting Guidelines - Non Clinical Trials

Type of Event

Who Reports

To Who

How

When

Adverse Events

CPI or PI HREC
  • Adverse Event Form
24 hours of becoming aware of the event.

Serious Adverse Events

CPI or PI HREC
  • Adverse Event Form
24 hours of becoming aware of the event.

Significant Safety Issue

(without an Urgent Safety Measure).

CPI or PI HREC
  • SSI notification form
24 hours of becoming aware of the event
Significant Safety Issue that meets the definition of an Urgent Safety Measure CPI or PI HREC
  • SSI notification form
Immediately after an urgent safety measure has been put in place to eliminate an immediate hazard to a participants health or safety.

Annual safety report

CPI or PI

HREC

  • Annual Progress Report

Annual as required by the HREC

Protocol Deviation

CPI or PI

HREC

  • Protocol Deviation Report Form

24 hours of becoming aware of the event

 

Definitions

Adverse event (AE): Any untoward medical occurrence in a research participant that does not necessarily have a causal relationship with the research intervention and is not related to any of the research methods.

Adverse Reaction (AR):  Any untoward medical occurrence in a research participant that does not necessarily have a causal relationship with the research intervention and is related to  the research methods.

Serious Adverse Events (SAE): Any adverse event/adverse reaction that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect and is not  research intervention.

Serious Adverse Reaction(SAR):Any adverse event/adverse reaction that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect and is related to the research intervention.

Suspected Unexpected Serious Adverse Reaction (SUSAR): An adverse reaction that is both serious and unexpected.

Unexpected Adverse Reaction (UAR): An adverse reaction, the which is not consistent with the research interventions known discomforts or risks

Significant Safety Issue (SSI): A safety issue that could adversely affect the safety of participants or materially impact on the continued ethical acceptability or conduct of the trial.

Urgent Safety Measure: A measure required to be taken in order to eliminate an immediate hazard to a participant’s health or safety.

PI: The person responsible, individually or as a leader of the research team at a site, for the research project at that site. In a single centre trial, the principal investigator may also be the coordinating principal investigator.

CPI: Coordinating Principal Investigator as defined below:

  • In relation to a research project conducted at a single trial site, the principal investigator at that site
  • In relation to a research project at more than one trial site, the health professional, whether or not he or she is an investigator at any particular site, who takes primary responsibility for the conduct of the trial.

Site Governance Officer: The person responsible for the governance of the sites where a safety event occurs.

HREC: The human research ethics committee that reviewed and approved research project.

 

 

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