Regulatory Submission

TASK has a dedicated in-house Regulatory Team that provides various regulatory services.

Established in 2005 |  Number of studies submitted to date = 40+ |  Tuberculosis = 30+ | Biobanking = 4 |  Wound care = 1 | COVID-19 = 1 |  South African Government COVID-19 |  Vaccine roll out study = 1 | Trials submitted for multiple sites = 9

 

Services include:

SAHPRA SUBMISSIONS

Clinical trials conducted in South Africa (SA) require approval from the South African Health Products Regulatory Authority” (SAHPRA).
TASK Regulatory submits initial applications, amendments to protocols and ongoing study communications on behalf of Sponsors conducting trials in SA, as per Good Clinical Practice (GCP) guidelines.

ETHICS SUBMISSIONS

Approval from an ethics committee before a human trial commences is required by most world regulatory authorities and is law in SA as per the National Health Act.

TASK Regulatory submits initial applications, amendments to protocols and ongoing study communications on behalf of Sponsors conducting trials in South Africa, as per Good Clinical Practice (GCP) guidelines. Pharma-Ethics is a listed vendor which is registered with the centralized National Health Research Ethics Committee (NHREC)

INFORMED CONSENT FORM (ICF) REVIEW

Each ethics committee has their own requirements that should be included in a trial ICF. All ICFs must be reviewed, approved, translated and translations notified to ethics before implementation of the forms. TASK Regulatory performs this on the trial sponsors behalf.

CLINICAL TRIAL REGISTRATION

Trial sponsors are required to register their trials on a clinical trial registry. This includes but is not limited to: the South African National Clinical Trial Registry (SANCTR); National Institute of Health (NIH) registry and the Pan-African Clinical Trial registry (PACTR).

TASK Regulatory registers trials on behalf of sponsors and updates the registries throughout the conduct of the trial until completion.

INVESTIGATOR SITE FILE (ISF) SETUP

It is the responsibility of the Principal Investigator (PI) of each trial to compile and maintain their site’s files. TASK Regulatory can create the ISF on behalf of other sites participating on a multi-centre sponsor trial.

TRIAL MASTER FILES (TMF) SETUP

It is the responsibility of the Sponsor to setup and maintain the TMF. This can be done either in hard copy or electronically. This can be delegated to TASK Regulatory.