SOPs should be reviewed before any new clinical trial and every [second] year if trials are active during that period; however deficiencies in existing SOPs noted at any time (by any member of the [research which require action are raised and dealt with at the earliest opportunity. group]) New SOPs may also be suggested via email by any member of the [research for group] consideration by the [research The latter will facilitate a meeting of relevant group management]. key members of the [research to decide whether the new SOP is required and, if so, an group] outline for its contents and assignment of author/reviewer. In case of revisions, a summary of any changes are kept in the document history section. The revised SOP will be assigned a new version number/date according to a standard format. References 21 CFR 312.60 General Responsibilities of Investigators – Guideline Good Clinical Practice ICH Guidelines for Good Clinical Practice (E6) ICH Guidelines for Good Clinical Practice (E6) section 3.1 Responsibilities – Schedule Y : Responsibility of Investigator Document history Version Date Reviewer Details of changes no. 1 Not applicable, first version
SOPs should be reviewed before any new clinical trial and every [second] year if trials are active during that period; however deficiencies in existing SOPs noted at any time (by any member of the [research group]) which require action are raised and dealt with at the earliest opportunity. New SOPs may also be suggested via email by any member of the [research group] for consideration by the [research group management]. The latter will facilitate a meeting of relevant key members of the [research group] to decide whether the new SOP is required and, if so, an outline for its contents and assignment of author/reviewer. In case of revisions, a summary of any changes are kept in the document history section. The revised SOP will be assigned a new version number/date according to a standard format. References 21 CFR 312.60 – General Responsibilities of Investigators Guideline Good Clinical Practice ICH Guidelines for Good Clinical Practice (E6) ICH Guidelines for Good Clinical Practice (E6) section 3.1 – Responsibilities Schedule Y : Responsibility of Investigator Document history Version no. Date Reviewer Details of changes 1 Not applicable, first version
Study_Team_Responsibilities_SOP.docx