Important information regarding GCP training due to COVID-19

In line with MH's response to the COVID-19 situation, including the requirement to implement social distancing measures to the greatest extent possible, the following changes to the GCP training requirements and session have been implemented until further notice:

  • Face to face training - sessions have been suspended until further notice.
  • Extension of approval periods - MH will extend the approval period of current face to face OR online training that expires in 2020 for one (1) year (i.e. a GCP training certificate attained on 5 April 2017 would normally expire by 5 April 2020, but the approval period is currently extended to 5 April 2021 ).
  • Online training - for the remainder of 2020 research staff may complete of online GCP training for courses that meet the minimum criteria set out by TransCelerate Biopharma Inc. and appear on the list of courses located on the TransCelerate Biopharma Inc. website.
  • Online training will be recognised for a period of one year. Research staff who undertake the online training will be required to complete a face to face GCP training session within 12 months of the date of the certificate.

For updates on how COVID-19 impacts research (including review of new applications and management of ongoing studies) and updated requirements at Melbourne Health please visit our COVID-19 webpage.


Good clinical practice (GCP) is the international standard for conducting clinical research.

GCP training requirements for MH staff

  • MH has implemented the requirement that all members of Melbourne Health research teams, including Principal Investigators, Associate Investigators, Research Nurses and Research Coordinators/Managers, conducting research at MH hold current, formal GCP certification training.
  • The GCP training must meet the minimum criteria set out by TransCelerate Biopharma Inc. and appears on the list of courses located on the TransCelerate Biopharma Inc. website.

Face-to-face GCP training schedule

  • Face-to-face GCP training has been suspended until further notice.

Online training - interim arrangements

  • For the remainder of 2020 research staff may complete of online GCP training in place of face-to-face GCP training.
  • Online GCP training courses must still meet the minimum criteria set out by TransCelerate Biopharma Inc. and appear on the list of courses located on the TransCelerate Biopharma Inc. website.
  • On completion of online training courses you will need to print out the certificate of completion for your files and forward a copy to the Office for Research.
  • For overseas based on-line training, some information is incorrect or not applicable for Australian researchers. Refer to the information provided on page 2 of the online training supplement for a summary of the Australian updates.

MH employees:

  • Email sarah.rickard@mh.org.au to arrange access to online GCP training available for Melbourne Health staff.
  • Online training will be recognised for a period of one year. Research staff who undertake the online training will be required to complete a face to face GCP training session within 12 months of the date of the certificate.

Students:

  • Only University of Melbourne MDRP students undertaking activities at MH may complete an online GCP training managed by the Office for Research.
  • The MH student supervisor, or the student (with cc to MH student supervisor), should contact the MH Manager Research Governance and Audit by email at sarah.rickard@mh.org.au to request online training. Please include confirmation that the MDRP student is undertaking activities at MH, the host department and provide the students MH email address. There is no cost for online training.

Alternative online GCP training courses

  • Staff may complete any online GCP training for courses that meet the minimum criteria set out by TransCelerate Biopharma Inc. and appears on the list of courses located on the TransCelerate Biopharma Inc. website. Several choices are available on the online training supplement .
  • For overseas based on-line training, some information is incorrect or not applicable for Australian researchers. Refer to the information provided on page 2 of the online training supplement for a summary of the Australian updates.
  • The MH Office for Research is not responsible for payment of fees incurred from external training, inlcuding online training.

Quick reference information to complement GCP

IQVIA (formally Quintiles) have provided handy information cards to assist researchers and research coordinators in management of their studies. These cards have been provided by IQVIA to Melbourne Health because we are IQVIA's prime site in Australia. Reading these cards is for information only and does not constitute GCP certified training.

IMPORTANT NOTE:

  • These cards are IQVIA’s proprietary information and should not be removed from Melbourne Health or shared with any third party.
  • The documents are an aid and do not replace any regulatory documents or Melbourne Health SOPs.
  • These materials do not constitute legal advice.

If you have any questions regarding the content of these cards, please contact your IQVIA study Monitor or the Office for Research at researchgovernance@mh.org.au.


GCP Frequently Asked Questions

What is the Good Clinical Practice (GCP) Guideline?

Good clinical practice (GCP) is the international standard for conducting clinical research and provides a framework for ensuring participants rights safety and well-being are protected and the data generated is credible. The GCP guideline details the requirements for stakeholder responsibilities, participant consent, documentation, protocols and amendments, requirements such as indemnity, reporting lines for adverse events and provision of medical care for trial participants. Originally developed for pharmaceutical trials, this guidance has become known as the “Good Clinical Practice” (GCP) guideline has becoming widely adopted as the standard for all clinical research.

The Therapeutic Goods Administration (TGA) has also adopted the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceutical for Human Use (ICH) GCP guidelines in Australia. The TGA has provided advice on the guideline relevant to the Australian context on the TGA website.

Who needs GCP training?

All MH researchers conducting clinical research at MH must hold current, formal GCP certification training. This includes Principal Investigators, Associate Investigators, Research Nurses and Coordinators/Managers.

Does the requirement for GCP training apply only to researchers conducting clinical trials?

No; all members of MH researcher teams conducting clinical research at MH must hold current, formal GCP certification training. This include the study principal investigator, associate investigators, research nurses and coordinators, data managers.

The clinical research may be Quality Assurance studies, retrospective audits, clinical research or clinical trials.

How can I access the GCP Guideline

Click here to access the current GCP guideline (revision 2) from the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceutical for Human Use (ICH) website.

What type of GCP courses are available at Melbourne Health?

Face-to-face and online GCP training courses are available.

Face-to-face training - currently suspended

Face to face GCP training is mandatory for all MH members of MH research teams.

MH run training sessions and online training is available via the Office for Research.

Face-to-face training is provided on site at MH and is the preferred training method as the sessions are interactive and researchers can ask questions that are applicable to their research study.

Research staff that complete online training may be asked to complete face-to-face GCP training prior to the expiry of their current GCP certificate.

Online training

Melbourne Health also has access to an online training program which is available to MH employees and University of Melbourne MDRP students undertaking activities at MH.

For students - the MH student supervisor, or the student (with cc to MH student supervisor), should contact the MH Manager Research Governance and Audit by email at sarah.rickard@mh.org.au to request online training. Please include confirmation that the MDRP student is undertaking activities at MH, the host department and provide the students MH email address. There is no cost for online training.

How do I access GCP training?

Via the Melbourne Health Office for Research

You can book into a training session using the links on this page.

For online training and queries, email the Manager Research Governance and Audit at sarah.rickard@mh.org.au.

Other courses*

MH research staff are also able to access face to face GCP training from external training providers. The MH Office for Research is not responsible for payment of fees incurred from external training.

*Remember to ensure that any GCP training you complete meets MH requirements i.e. is face to face and meets the minimum criteria set out by TransCelerate Biopharma Inc. and that the training provider appears on the list of courses on TransCelerate Biopharma Inc. web page.

What GCP training is acceptable

MH has adopted the minimum standards defined by TransCelerate Biopharma Inc. to recognise GCP training courses that contain material meeting the minimum criteria agreed to by its member organisations. Acceptable GCP training courses are those listed on TransCelerate Biopharma Inc.

What do I do with my GCP certificate

Principal Investigators (PI) are required to provide evidence that all MH researchers and staff involved in the conduct of a research study at MH are appropriately qualified, including holding current GCP certification. Therefore, you should:

  1. File the GCP certificate in your training record;
  2. Provide a copy of the GCP certificate to the PI and/or coordinator for each clinical research project that you are involved in; and
  3. Forward a copy of the GCP certificate to the Office for Research.

GCP certificates for all MH researcher team members should be included in the study research governance application submitted to the Office for Research.

How long does GCP certification last?

GCP certification is valid for three years unless the certification period stated on the GCP certificate is less than 3 years.

  • For instance, if the certificate does not specify an expiry date, MH recognises GCP certification for three years.
  • If the certificate states a two-year expiry date, then GCP training will be required after two years.

TEMPORARY Extension of approval periods - MH will extend the approval period of current face to face OR online training that expires in 2020 for one (1) year (i.e. a GCP training certificate attained on 5 April 2017 would normally expire by 5 April 2020, but the approval period is currently extended to 5 April 2021

What happens when my GCP certification expires?

If you are still involved in clinical research at MH, then you will need to update your GCP training by completing another GCP training course, this may be a refresher course.

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