NHS permissions (if applicable) To document NHS permission X X X including application, approval was gained for an individual NHS letter and correspondence site to participate in the trial Regulatory Authority(ies) To document appropriate X X X authorisation by the regulatory Clinical Trial Authorisation, authority(ies) has been obtained including maintaining to initiation of the trial in authorisation following changes to compliance with the applicable the trial. regulatory requirement(s), and to required) document that the authorisation is maintained throughout the trial. Documents include the application form and correspondence. Other relevant approvals, e.g. To document any other X X X ARSAC, HBRC including appropriate approvals has been maintaining approval following obtained prior to initiation, and to changes to the trial. application document that the authorisation forms, approval letters and is maintained throughout the trial. correspondence, Documents include the application form and (where required) correspondence. Interim or Annual Reports to REC Interim or annual reports X X X and Authority(ies) (where provided to REC in accordance required) with 4.10 (ICH GCP) and to authority(ies) Curriculum Vitae and/or other To document qualifications and X X X (CI only) relevant documents evidencing eligibility to conduct trial and/or qualifications of Investigator(s) provide medical supervision of and Sub-Investigator(s) including subjects This includes GCP training. It is recommended that
NHS permissions (if applicable) including application, approval letter and correspondence To document NHS permission was gained for an individual NHS site to participate in the trial X X X Regulatory Authority(ies) Clinical Trial Authorisation, including maintaining authorisation following changes to the trial. required) To document appropriate authorisation by the regulatory authority(ies) has been obtained to initiation of 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. X X X Other relevant approvals, e.g. ARSAC, HBRC including maintaining approval following changes to the trial. application forms, approval letters and correspondence, (where required) To document any other 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 To document qualifications and eligibility to conduct trial and/or provide medical supervision of subjects This includes GCP training. It is recommended that X X X (CI only)
UoB-CLN-ESD-QCD-001-Essential-Document-Checklist-CTIMPs-v.-2.0-dd01-Mar-2016.docx