书面报告的基本要求.ppt

What Should be Covered in Every Written Report Administrative information Reason for the inspection Extent of the inspection Individual responsibilities at the site Inspectional findings With cross-reference to exhibits Summary of the Close-out discussion Including any response(s) by the inspected party Administrative Information -1- Provides basic background information May be developed as a “cover sheet” to the inspection report Administrative Information -2- Information that should be included: Application number (or other identifying number used by the regulatory authority) Dates of Inspection Name of the inspector/members of the inspection team Name of the CI/inspected party Location (Address and contact details) of the inspected site Study sponsor Administrative Information -3- Protocol title and number (including identity of the investigational product[s]) Dates of the study (overall; and also start date at the inspected site) Identity of the Ethics Committee (including contact information) Site personnel interviewed or accompanying during the inspection Prior regulatory inspection history of the investigator and/or site Administrative Information -4- For China, it may also be important to include information about the institution: Such as contact information, institutional approval to conduct the study (approval number; valid dates), and date/results of the institution’s most recent inspection Reason for Inspection Keep this very short Identify who requested/initiated the inspection assignment (e.g., headquarters; local office) State the purpose of the inspection Routine (Surveillance, or in support of a Marketing Application) Follow-Up For Cause (Internal Concerns or External Complaint) Other Extent of the Inspection -1- Start by referencing the SOP (if any) followed by the inspectors For example, “The inspection followed the procedures in CPGM xxx” Briefly describe the conduct of the inspection 1) If a team inspection, state this and briefly indicate the