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SA GCP UPDATE What you need to know-2

SA GCP Third edition: What you need to know

Let’s talk clinical trials – a TASK Academy series – article #5 –

 

SA GCP THIRD EDITION 2020 IS HERE -WHAT YOU NEED TO KNOW

 

At long last we can celebrate the birth of our proudly South African Good Clinical Practice (SA GCP) guidelines, third edition 2020 (https://www.sahpra.org.za/guidelines-notice-board/). It was published on 15 June 2021 and the South African Clinical Trial industry is given until 1 October 2021 to train all staff and implement the new guidelines.

Why do we have guidelines? What triggered the start of the guidelines? Is SA GCP the only guideline to follow? What is the difference between ICH GCP and SA GCP? When do you follow what guideline? Is SA GCP a legal requirement? These are some of the many questions that we address during our TASK Academy ICH / SA GCP Beginner’s course.  Today, however, I want to address the more pressing questions we have received of late:

  • What are the headline changes to the third edition of SA GCP?
  • Who is affected by these changes?
  • How can we be compliant?

What are the headline changes to the third edition of SA GCP?

This seems like an easy question deserving of a straightforward answer, but unfortunately it is not. There was a big departure from the previous version. What I can safely say is that all necessary information incorporated in SA GCP 2006 is included in SA GCP 2020. Some information is consolidated, some is revised and updated, but in my opinion, quite a bit was reorganised in pursuit of providing more user-friendly, informative guidelines for designing, conducting, monitoring, recording, analysing, and reporting trials in South Africa.

It is still closely aligned with the ICH GCP (R2) E6 (international) guidelines for the conduct of trials, but now also aligned with the South African Health Products Regulatory Authority (SAHPRA) Clinical Trial Committee (CTC) policies.

So – to break it down:

Its not just GCP:

SA GCP (section 1.2.2) again makes us aware that all role players should be familiar with not only GCP, but also the latest versions of various other national and international guidelines. There is specific emphasis placed on the fact that SA GCP does not repeat the ethical principles which are outlined in the Department of Health’s Ethics in Health Research: Principles, Processes and Structures 2nd edition, 2015.  https://www.ru.ac.za/media/rhodesuniversity/content/ethics/documents/nationalguidelines/DOH_(2015)_Ethics_in_health_research_Principles,_processes_and_structures.pdf. This document is referenced throughout SA GCP 2020 and I would highly recommend all role players to familiarize themselves with these ethical guidelines – reading it in conjunction with SA GCP.

Key concepts in Clinical Trials:

The 9 key concepts that are addressed in section 2 of SA GCP are aligned with the 13 key principles of ICH GCP (R2) E6. However, there are some unique SA GCP key concepts that are also addressed:

  • Reimbursement and how it should be calculated – especially when conducting multi-national trials.
  • Data management and the responsibility of the sponsor to report the trial outcome to the principal investigator (PI) and SAHPRA, as well as to the Department of Health (DoH) via the South African National Clinical Trials Registry (SANCTR), and together with the PI, appropriately share/ disseminate the clinical trial results, including providing feedback to participant communities where appropriate. Results should be disclosed within one year of completion of analysis of the trial results. For collaborative studies and multi-centre trials, publication conditions must be clearly described in the protocol, and approved by the relevant regulatory authorities.

Uniquely South African concepts:

An entire section (section 3) is dedicated to addressing the management of recruitment of vulnerable participants, again referencing the DoH 2015 guideline. SA GCP requires that the research proposal include descriptions of the anticipated method through which findings may be translated into mechanisms to improve the health status of South Africans. The social context of the proposed research population and the measures to protect against unfair exploitation or increasing the vulnerability of potential participants must be described.

Section 4 is dedicated to exploring various regulatory authority roles and responsibilities in the South African context. This section introduces you to the National Health Research Ethics Council (NHREC), SAHPRA, our research ethics committees membership requirements, how they should retain their records and train their members, the South African National Clinical Trials Register (SANCTR: www.sanctr.gov.za) (where all South-African based trials need to be registered by sponsor / PI or applicant for a unique number before a trial may commence), and last but not least, introduction to Provincial Health Research Committees (PHRC).

Principal Investigator (PI) oversight:

If you are working in trials, you will be familiar with the responsibilities of the investigator in a clinical trial. If not, my previous post (Physician vs Investigator) explains how being an investigator is different to that of a physician. 

Section 5, for the first time, explains the various categories of investigators in the South African context. This continues to align with ICH GCP (R2) E6 regarding investigator responsibilities, also addressing electronic data handling and requirements for computer systems.

An entire sub-section (5.10) is dedicated to PI responsibilities, and describes the expected oversight needed by a PI for a trial in South Africa. It further states that having an “absentee” PI based in another country is unacceptable.

Ethical considerations impacting protocol approval:

To ensure an effective SAHPRA board review and approval, your protocol design and Clinical Trial application form (CTF 1) should describe:

  • That the research question under consideration has not been previously substantively answered.
  • How your findings will translate into mechanisms to improve the health status of South Africans.
  • The social context of the proposed research population and the measures to protect against unfair exploitation or increasing the vulnerability of potential participants.
  • How multi-centre or multi-national trials with international research groups must comply with all local (i.e. South African) regulatory requirements.
  • That local South African realities and context were considered and appropriately integrated into the protocol design.
  • That a reasonable proportion of significant project team members are South African researchers, including those from previously disadvantaged backgrounds.
  • The reason and justification as to why South Africa was selected as a clinical trial site, but the country of origin or other high-income countries were not.

Other relevant considerations:

The final section in the updated SA GCP 2020 (section 10) is an entirely new addition and addresses very relevant clinical trial concepts that makes for excellent and highly recommended bedtime reading:

  • Conflict of Interest
  • Insurance Against Trial-Related Injuries
  • Professional Indemnity
  • Sponsor Indemnification
  • Continuing Care After Research (Post Clinical Trial Access)
  • Assessing Safety and Minimizing Risk
  • Human Reproduction Considerations
  • New Technologies
  • Electronic Signatures
  • Therapeutic Misconception and Dual Roles
  • Conducting Clinical Trials during a Pandemic

Who is affected by these changes?

If you are designing, conducting, managing, monitoring, recording / capturing data, analyzing and / or reporting on a clinical trial that will be, or is currently conducted in South Africa, you are legally required to follow and implement the changes documented in SA GCP 2020. Compliance with these guidelines is compulsory under the direction of the Director-General of Health. These guidelines are established in terms of Regulations issued in terms of section 90(s) and in terms of 72(6)(c) of the National Health Act No, 61 of 2003 as well as Regulation 30 of the Medicines and Related Substances Act, Act No 101 of 1965.

How can we be compliant?

The third edition of SA GCP 2020 was published on the SAHPRA website and is freely available for distribution. I believe that if you are experienced in the conduct of research in the South African context, and knowledgeable about SA GCP edition 2 guidelines (2006), you can download the updated edition and perform a self-study. As per good documentation practice, you should record your self-training, however, as previously stated, this version is a big departure from the previous version. Training by a reputable organization is recommended. You have until 1 October 2021 to ensure all staff are trained on the updates and that SA GCP third edition is implemented at your site going forward. You can reach out to TASK Academy for this training by clicking the link and completing the contact form here: Academy

In summary

South Africa is home to many vulnerable groups of poor populations – thus the potential for misuse of power cannot be ignored. Costs for sponsors to conduct trials in South Africa is lower than in many other countries with similar standards. Trials in South Africa also carry less chance of litigation. South Africa is a valuable “gateway” for launching clinical research efforts northwards into the rest of Africa. We therefore need good clinical practice guidelines specific to the South African context.

  • The conduct of clinical trials in South Africa is detailed in SA GCP third edition 2020.
  • The research infrastructure and research ethics is detailed in the DoH 2015 guidelines.
  • Researchers will need to follow both SA GCP and DoH guidelines.
  • In the event of an interpretation conflict between these guidelines (SA GCP 2020) and an international guideline, SA GCP 2020 takes precedence.
  • Where there is a conflict between SA GCP 2020 and a South African legal requirement, where both appear to address the same issue or activity, generally, the legal requirement should take precedence, unless an ethical or GCP justification clearly demonstrates otherwise.
  • It is advisable for Research Ethics Committees (RECs) to consult with the National Health Research Ethics Council (NHREC) and / or SAHPRA regarding which takes precedence to promote standardisation.

Some of the information included in this article is based on the original presentation of Professor Lesley Burgess at the CTC stakeholders meeting held 1 July, 2021

 

Till next time,

Karen Cloete 

Head Quality Assurance and Regulatory, Founder TASK Academy

With years of hands-on experience and under the leadership of Karen Cloete, TASK Quality and Regulatory team ensures high-quality standard and GCP compliance of all trials conducted at TASK. Through the academy clinical trial training and capacity development services are also provided.

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