authorisation following changes to the trial in compliance with the applicable regulatory the trial. requirement(s), and to (where required) document that the authorisation is maintained throughout the trial. Documents include the application form and correspondence. relevant approvals, e.g. To document any X X X appropriate approvals has ARSAC, HBRC including been obtained prior to maintaining approval following initiation, and to document that changes to the trial. application the authorisation is maintained forms, approval letters and throughout the trial. correspondence, Documents include the required) application form and correspondence. Interim or Annual Reports to REC Interim or annual reports X X X provided to REC in and Authority(ies) (where accordance with 4.10 (ICH required) GCP) and to authority(ies) Curriculum Vitae and/or other To document qualifications X X X (CI only) and eligibility to conduct trial relevant documents evidencing and/or provide medical qualifications of Investigator(s) supervision of subjects This and Sub-Investigator(s) including includes GCP training. It is any revisions and Curriculum recommended that you sign Vitae for new Investigators and date the documents as this will allow the reviewer to assess how recent the information is. Signature X X To document signatures and initials of all persons
authorisation following changes to the trial. (where required) the trial in compliance with the applicable regulatory requirement(s), and to document that the authorisation is maintained throughout the trial. Documents include the application form and correspondence. relevant approvals, e.g. ARSAC, HBRC including maintaining approval following changes to the trial. application forms, approval letters and correspondence, required) To document any appropriate approvals has been obtained prior to initiation, and to document that the authorisation is maintained throughout the trial. Documents include the application form and correspondence. X X X Interim or Annual Reports to REC and Authority(ies) (where required) Interim or annual reports provided to REC in accordance with 4.10 (ICH GCP) and to authority(ies) X X X Curriculum Vitae and/or other relevant documents evidencing qualifications of Investigator(s) and Sub-Investigator(s) including any revisions and Curriculum Vitae for new Investigators To document qualifications and eligibility to conduct trial and/or provide medical supervision of subjects This includes GCP training. It is recommended that you sign and date the documents as this will allow the reviewer to assess how recent the information is. X X X (CI only) Signature To document signatures and initials of all persons X X