Forms & Instructions

Download the non-linked forms listed below from the central forms repository.

New Protocol Applications

• New protocol application and submission instructions for researchers (fhs013hlp) 21.02.2019

• New protocol application form - Section A (FHS013) 21.02.2019

• Checklist for new protocol applications

• Applicants for databases, registries or repositories should only fill out form (FHS020) 13.02.2017

• 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)

Informed Consent - (Please also see Standard Operating Procedures)

• H3Africa Guidelines for Informed Consent [Download]

Insurance

• 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.]

Accessing Staff or Students for research purposes

• Research Access to students (DSA 100)

• Access to UCT Staff for Research Purposes (HR194 & HR190)

Active Protocols

• Preparing an amendment - Pointers for researchers (FHS006hlp) 21.02.2019

• Notice of HREC Amendment Requirements [Download]

• Protocol amendment form (FHS006) 21.02.2019

• Amendment form- study staff (FHS007) 12.09.2016

• 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) 12.03.2018

• Reporting form for safety information (FHS009) 12.03.2018

• Study closure report (FHS010) 11.09.2014

• Final Report - for Record Reviews/Audits/Collection of Biological Specimens/Repositories/Databases/Registries (FHS019) 18.09.2014

• Study exceptions and study deviations - pointers for researchers (FHS011hlp) 23.07.2014

• Study deviation form (FHS011) 20.06.2016

• Study exception form (FHS012) 20.06.2016

Continuing Review (Annual Progress Reports)

• Annual progress report - Pointers for researchers (FHS016hlp)

• Annual Progress Report (FHS016) 21.02.2019

• Annual progress Report (FHS017) 23.07.2014 for Record Reviews/Audits/Collection of Biological Specimens/Repositories/Databases/Registries