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

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