South Africa has its own national registry, South African National Clinical Trial Registry (SANCTR). SANCTR is not a World Health Organization (WHO) recognized primary registry. It has a provision for registering studies conducted in South Africa. All new clinical trials from 1st December 2005 or the trials that started recruiting as of 1st July 2005 must be registered on SANCTR. Additionally, protocol registration and results posting can be done voluntarily on Pan African Clinical Trial Registry, which is a WHO recognized primary registry.
| Registries at a Glance | |||||
| Registry | PHUSE Categorization | Information to be Entered By | Route of Data in Registry | Study Type | Language |
| SANCTR | Mandatory National Database (includes Ethics Requirement) | Investigator, Sponsor | Through a dedicated registration platform (process independent from clinical trial application) |
Interventional (Phase 1-4);Observational |
English |
| Registration and Results Requirements | |||
| Registry | Activity | Legal Requirement | Timing |
| SANCTR | Registration |
Yes |
Prior to first patient enrollment |
| Results |
Yes |
Within one year of completion of analysis of the study results | |
Registry Updates
- June 2020: South Africa Regulatory Update - Introducing a New Online Platform for African Trials The African Academy of Sciences (AAS) in June 2020, launched a first iteration of the Clinical Trials Community (CTC) online platform with features that will increase the visibility of African clinical trial sites and investigators with potential to participate in COVID-19 clinical trials. This platform will promote … Continue reading "June 2020: South Africa Regulatory Update"
References
- South African Good Clinical Practice: Clinical Trial Guidelines- https://www.sahpra.org.za/wp-content/uploads/2020/01/31828e7f4thCombinedChapt3rdRevisedNHREC_CTC_SAGCP24May2019_v3clean_Draftforcomment__10.07.2019.pdf . Published 2019. Accessed 2019.