Forms & Instructions

New Protocol Applications

New protocol application and submission instructions for researchers
New protocol application form - Section A
Checklist for new protocol applications
Applicants for databases, registries or repositories should only fill out form (FHS020) 31.03.2020
New Undergraduate student research protocol application form (FHS021 ) 21.02.2019
Checklist for new undergraduate protocol applications
Preparing a Synopsis: Section B - Pointers for Researchers (FHS014)
Preparing the Research Protocol Section C - Pointers for Researchers (FHS015hlp) 21.02.2019
Research Protocol Section C (FHS015) 12.03.2018
Eligibility for Expedited Review of US Federally-funded Research - Pointers for Researchers[Download]
New Protocol Applications - Pointers for Reviewers [Download]
Research Requirements to conduct research at Red Cross War Memorial Children's Hospital[Download]
Application form to conduct research at Red Cross War Memorial Children's Hospital[Download ]

Requirements for research in minors <18 years of age (Form A)

Federal Wide Assurance (FWA) for the Protection of Human Subjects [Download]
Institutional Review Board (IRB) Registration
Insurance cover for investigators on clinical trials [This insurance cover is in place for investigators on clinical trials. This cover is for malpractice and indemnity for staff engaged in clinical trials, where appropriate. This cover is distinct from the no-fault insurance cover provided to patients who are involved in UCT clinical trials.]

Preparing an amendment - Pointers for researchers (FHS006hlp) 21.02.2019
Notice of HREC Amendment Requirements [Download]
Protocol amendment form (FHS006) 25.03.2020
Amendment form- study staff (FHS007) 25.03.2020
Preparing an Internal Adverse Event or Unanticipated Problem report - Pointers for researchers(FHS008hlp) 12.03.2018
Internal Adverse Event or Unanticipated Problem reporting form (FHS008) 25.03.2020
Reporting form for safety information (FHS009) 25.03.2020
Study closure report (FHS010) 25.03.2020
Final Report - for Record Reviews/Audits/Collection of Biological Specimens/Repositories/Databases/Registries (FHS019) 25.03.2020
Study exceptions and study deviations - pointers for researchers (FHS011hlp) 23.07.2014
Study deviation form (FHS011) 25.03.2020
Study exception form (FHS012) 25.03.2020

Annual progress report - Pointers for researchers (FHS016hlp)
Annual Progress Report (FHS016) 25.03.2020
Annual progress Report (FHS017) 25.03.2020 for Record Reviews/Audits/Collection of Biological Specimens/Repositories/Databases/Registries