Develop and implement a biospecimen QA/QC program for central laboratories and/or □ 9 biorepositories. B. Quality Control (QC) Identify lead QC staff. □ 1 □ Maintain QC procedures and schedules. 2 □ Provide QC reports in a timely manner. 3 Outline a plan for testing key protocol processes and procedures (simulating visits, □ 4 forms completion with sham data etc.). Have processes documented for establishing and reviewing DCC Standard Operating □ 5 Procedures, checklists and □ Address and document responses and corrections to identified problems. 6 □ Document and follow procedures for identifying and correcting possible data errors. 7 □ Document and follow procedures for quantifying measurement errors in key variables. 8 Document and follow procedures for handling protocol deviations/violations. Evaluate the □ QC program regularly, making adjustments as needed based on feedback from the clinical 9 sites and monitors. Introduce statistical monitoring to examine aggregate data and identify potential site □ 10 variations. Conduct process reviews during the study to ensure that the study is implemented □ 11 appropriately at study sites and procedures at DCC are robust. HUMAN SUBJECTS PROTECTION/REGULATORY AFFAIRS A. Human Subject Protections Have a system is in place to track the human subjects’ protection training of appropriate □ 1 study staff. □ Collaborate with investigators to create and distribute the consent document template(s). 2 Ensure that the IRB-approved informed consent forms at clinical sites have required □ elements and are factually correct (including back-translation of documents written in 3 languages other than English). Review consent documents for signatures and use of the IRB date stamped form during site □ 4 visits. Develop a well-defined reporting process for adverse events (AE) and unanticipated □ problems (as defined by OHRP) that is defined precisely and is in compliance with local IRB requirements, 21 CFR 312.32 for Investigational New Drugs (IND), 21 CFR 812.150 5 for Investigational Device Exemptions (IDE), and International Conference on Harmonisation Regulations E2A, as applicable. Implement a plan to report safety analyses
9 Develop and implement a biospecimen QA/QC program for central laboratories and/or biorepositories. □ B. Quality Control (QC) 1 Identify lead QC staff. □ 2 Maintain QC procedures and schedules. □ 3 Provide QC reports in a timely manner. □ 4 Outline a plan for testing key protocol processes and procedures (simulating visits, forms completion with sham data etc.). □ 5 Have processes documented for establishing and reviewing DCC Standard Operating Procedures, checklists and □ 6 Address and document responses and corrections to identified problems. □ 7 Document and follow procedures for identifying and correcting possible data errors. □ 8 Document and follow procedures for quantifying measurement errors in key variables. □ 9 Document and follow procedures for handling protocol deviations/violations. Evaluate the QC program regularly, making adjustments as needed based on feedback from the clinical sites and monitors. □ 10 Introduce statistical monitoring to examine aggregate data and identify potential site variations. □ 11 Conduct process reviews during the study to ensure that the study is implemented appropriately at study sites and procedures at DCC are robust. □ HUMAN SUBJECTS PROTECTION/REGULATORY AFFAIRS A. Human Subject Protections 1 Have a system is in place to track the human subjects’ protection training of appropriate study staff. □ 2 Collaborate with investigators to create and distribute the consent document template(s). □ 3 Ensure that the IRB-approved informed consent forms at clinical sites have required elements and are factually correct (including back-translation of documents written in languages other than English). □ 4 Review consent documents for signatures and use of the IRB date stamped form during site visits. □ 5 Develop a well-defined reporting process for adverse events (AE) and unanticipated problems (as defined by OHRP) that is defined precisely and is in compliance with local IRB requirements, 21 CFR 312.32 for Investigational New Drugs (IND), 21 CFR 812.150 for Investigational Device Exemptions (IDE), and International Conference on Harmonisation Regulations E2A, as applicable. Implement a plan to report safety analyses □
DCC-CKlist-2011-10-14.docx