Date: IRB Number: Protocol Title: Principal Investigator: Deficiency Identified: out was used on case report forms. Compliance Review 8.1 Report Checklist Item Number: Response to Deficiency: Concur, white out was used to obscure incorrect study data entry. Corrective Action Plan: The study team will no longer allow the use of white out on study documents. Data entry will be made (Action taken to correct using only black ink. Corrections to data entry will be lined through once, initialed and dated, with an specific deficiency explanation as to why the changes were made. identified) Preventative Action Plan: All study team members will be re-trained on FDA and GCP regulations regarding proper data entry (Action to prevent the technique. The trainings will be documented in a training log form. reoccurrence of this problem in the future) Responsible Personnel: Jane Doe, MD Signature and Date: Date: IRB Number: Protocol Title: Principal Investigator:
Date: IRB Number: Protocol Title: Principal Investigator: Deficiency Identified: out was used on case report forms. Compliance Review Report Checklist Item Number: 8.1 Response to Deficiency: Concur, white out was used to obscure incorrect study data entry. Corrective Action Plan: (Action taken to correct specific deficiency identified) The study team will no longer allow the use of white out on study documents. Data entry will be made using only black ink. Corrections to data entry will be lined through once, initialed and dated, with an explanation as to why the changes were made. Preventative Action Plan: (Action to prevent the reoccurrence of this problem in the future) All study team members will be re-trained on FDA and GCP regulations regarding proper data entry technique. The trainings will be documented in a training log form. Responsible Personnel: Jane Doe, MD Signature and Date: Date: IRB Number: Protocol Title: Principal Investigator:
CAPA_Template-2018.06.01.docx