Good Clinical Practice is not a once-off certification — it is a working culture. Alpha CR Solutions delivers practical, South Africa-contextualised GCP training for investigative site teams at every level.
Covering all ICH E6(R2) GCP principles with South African regulatory context.
Designed for investigators, coordinators, pharmacists and data managers.
Delivered on-site at your facility or via live virtual session.
All participants receive a signed certificate of completion.
GCP applies to everyone involved in the conduct of a clinical trial. Our training is structured to be relevant and accessible for every role at site.
Responsibilities under ICH E6(R2), delegation of duties, oversight of study conduct, safety reporting obligations and regulatory accountability.
Day-to-day GCP application — informed consent, source documentation, CRF completion, query management, IMP handling and subject safety monitoring.
IMP accountability, storage, dispensing, temperature monitoring, reconciliation and regulatory requirements for investigational products under SAHPRA.
Source data standards, CRF completion requirements, data query processes, audit trails and data integrity obligations under ICH E6(R2).
Sample handling, chain of custody, laboratory documentation, normal ranges, critical value reporting and GCP obligations for central and local labs.
Foundation GCP training for staff who are new to clinical trials — covering the principles, regulatory framework and their role in protecting subjects and data.
All twelve modules are delivered in a logical sequence that mirrors the life cycle of a clinical trial — from protocol to archive.
Origins of GCP, the Declaration of Helsinki, Belmont Report and the ICH E6(R2) framework.
South African clinical trial legislation, SAHPRA's role, NHREC and institutional ethics requirements.
Roles, responsibilities and processes of ethics committees in South African clinical trials.
PI accountability, delegation logs, qualification requirements and oversight obligations.
Consent requirements, vulnerable populations, literacy considerations and re-consent obligations.
ALCOA-C principles, source data definition, acceptable source documents and common errors.
ICH E6(R2) essential documents list, TMF structure, maintenance and inspection readiness.
Receipt, storage, dispensing, reconciliation, temperature monitoring and destruction of investigational products.
Definitions, timelines, reporting pathways to SAHPRA, ethics committees and the sponsor.
Classification, documentation, reporting requirements and corrective/preventive action (CAPA) processes.
What RBM means for sites, what monitors look for, and how to prepare for monitoring visits.
What to expect during a sponsor audit or SAHPRA inspection, common findings and preparation strategies.
We adapt the training format to your team's schedule, location and size — without compromising the quality or depth of the programme.
Full-day training delivered at your site or a venue of your choosing. Ideal for full site teams of 5–30 participants. Includes printed reference materials and group exercises.
Live instructor-led training via video conference — ideal for geographically dispersed teams or sites that need to train staff without operational disruption.
Focused half-day sessions designed for a specific site role — pharmacists, data managers, or new coordinators — covering only the modules most relevant to their responsibilities.
GCP training from Alpha CR Solutions is not a box-ticking exercise. Participants leave with practical knowledge, useful reference materials, and a certificate that documents their compliance training for the Trial Master File.
Training records are issued to the site for inclusion in the TMF and are formatted to meet SAHPRA and sponsor audit requirements.
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