Profile on previous study i.e. Phase 1 & Phase II studies (where applicable) Investigator Agreement (PI’s responsibility), Page duly signed, with name and date. Current Certificate of Training in Good Clinical Practice (GCP) for PI(s) Investigational Product Brochure for the study Data Safety Monitoring (DSMB) membership and Charter of Work/Current Curriculum Vitae of members. Insurance cover for study participants Scientific review approval Food and Drugs Authority approval letter for use of the Investigational Product/ Devices and clinical trial approval (This should be submitted after ERC approval). Current CVs of PI & Co-Investigators (Abridged Three pages relating to current – work) Additional Requirements by Undergraduates, Masters and Postgraduate Students: Covering letter and CV of supervisor Covering letter from school/college Students not taking their academic programme in Ghana are required to identify a local supervisor and submit his/her covering letter and CV Number of Copies of Protocol for Submission: Institutional/Individual/PhD & Fellowship Students: Applicant shall submit thirteen (13) comb-bounded copies of the full research protocol with the items indicated and where applicable, and a CD version with protocol title and PI’s name stated on it Master/Undergraduate Student Protocols: Applicant shall submit of the full research four (4) comb-bounded copies protocol with the items indicated above and a CD of the protocol with the study title & PI’s name stated on it. Note#: One hard copy of the full protocol together of all supporting documents should first be submitted to the ERC Secretariat for verification before final submission ERC review Updated Version 3 dated October 23, 2018 - Property of GHS-ERC Secretariat only
Profile on previous study i.e. Phase 1 & Phase II studies (where applicable) Investigator Agreement (PI’s responsibility), Page duly signed, with name and date. Current Certificate of Training in Good Clinical Practice (GCP) for PI(s) Investigational Product Brochure for the study Data Safety Monitoring (DSMB) membership and Charter of Work/Current Curriculum Vitae of members. Insurance cover for study participants Scientific review approval Food and Drugs Authority approval letter for use of the Investigational Product/ Devices and clinical trial approval (This should be submitted after ERC approval). Current CVs of PI & Co-Investigators (Abridged – Three pages relating to current work) Additional Requirements by Undergraduates, Masters and Postgraduate Students: Covering letter and CV of supervisor Covering letter from school/college Students not taking their academic programme in Ghana are required to identify a local supervisor and submit his/her covering letter and CV Number of Copies of Protocol for Submission: Institutional/Individual/PhD & Fellowship Students: Applicant shall submit thirteen (13) comb-bounded copies of the full research protocol with the items indicated and where applicable, and a CD version with protocol title and PI’s name stated on it Master/Undergraduate Student Protocols: Applicant shall submit four (4) comb-bounded copies of the full research protocol with the items indicated above and a CD of the protocol with the study title & PI’s name stated on it. Note#: One hard copy of the full protocol together of all supporting documents should first be submitted to the ERC Secretariat for verification before final submission ERC review Updated Version 3 dated October 23, 2018 - Property of GHS-ERC Secretariat only
Requirements_For_Submission_of_Application_for_Ethical_Review_and_Approval_(Revised)_January_2018.docx