Common use of Data Quality Assurance Clause in Contracts

Data Quality Assurance. ‌ All patient data relating to the study will be recorded on printed or electronic CRF unless transmitted to the Sponsor or designee electronically (eg, laboratory data). The Investigator is responsible for verifying that data entries are accurate and correct by physically or electronically signing the CRF. The Investigator must maintain accurate documentation (source data) that supports the information entered in the CRF. The Investigator must permit study-related monitoring, audits, IRB/IEC review, and regulatory agency inspections and provide direct access to source data documents. Monitoring details describing strategy, methods, responsibilities and requirements, including handling of noncompliance issues and monitoring techniques (central, remote, or on-site monitoring) are provided in the Medical Monitoring, Safety Monitoring and Global Monitoring Plans. The Sponsor or designee is responsible for the data management of this study including quality checking of the data. The Sponsor assumes accountability for actions delegated to other individuals (eg, Contract Research Organizations [CRO]). Study monitors will perform ongoing source data verification to confirm that data entered into the CRF by authorized site personnel are accurate, complete, and verifiable from source documents; that the safety and rights of patients are being protected; and that the study is being conducted in accordance with the currently approved protocol and any other study agreements, ICH GCP, and all applicable regulatory requirements. Records and documents, including signed ICFs, pertaining to the conduct of this study must be retained by the Investigator for 2 years after the last marketing application approval, or if not approved, 2 years following the discontinuance of the study medication, unless local regulations or institutional policies require a longer retention period. No records may be destroyed during the retention period without the written approval of the Sponsor. No records may be transferred to another location or party without written notification to the Sponsor.

Data Quality Assurance. ‌ All patient subject data relating to the study will be recorded on printed or electronic CRF eCRFs unless transmitted to the Sponsor or designee electronically (eg, laboratory data). The Investigator is responsible for verifying that data entries are accurate and correct by physically or electronically signing the CRFeCRF. • The Investigator must maintain accurate documentation (source data) that supports the information entered in the CRFeCRF. • The Investigator must permit study-related monitoring, audits, IRB/IEC review, and regulatory agency inspections and provide direct access to source data documents. Monitoring details describing strategy, methods, responsibilities and requirements, including handling of noncompliance issues and monitoring techniques (central, remote, or on-site monitoring) are provided in the Medical Monitoring, Safety Monitoring and Global Monitoring Plans. • The Sponsor or designee is responsible for the data management of this study including quality checking of the data. The Sponsor assumes accountability for actions delegated Management of clinical data will be performed in accordance with applicable Sponsor-approved standards and data cleaning procedures to other individuals (eg, Contract Research Organizations [CRO])ensure the integrity of the data. • Study monitors will perform ongoing source data verification to confirm that data entered into the CRF eCRF by authorized site personnel are accurate, complete, and verifiable from source documents; that the safety and rights of patients subjects are being protected; and that the study is being conducted in accordance with the currently approved protocol and any other study agreements, ICH GCP, and all applicable regulatory requirements. Records and documents, including signed ICFs, pertaining to the conduct of this All clinical study documentation must be retained by the Investigator for until at least 2 years after the last approval of a marketing application approvalin an ICH region (ie, US, Europe, or Japan) and until there are no pending or contemplated marketing applications in an ICH region; or, if no application is filed or if the application is not approvedapproved for such indication, until 2 years following after the discontinuance investigation is discontinued and regulatory authorities have been notified. Investigators may be required to retain documents longer if required by applicable regulatory requirements, by local regulations, or by an agreement with the Sponsor. The Investigator must notify the Sponsor before destroying any clinical study records. The study site and the record retainer should take measures in such a way that these records are not lost or abandoned during the designated period of preservation and that they are presented upon request. The protocol, protocol amendments, informed consent form, Investigator’s Brochure, and any other relevant materials, including accompanying material to be provided to the subject (eg, advertisements, subject information sheets, or descriptions of the study medicationused to obtain informed consent) will be submitted by the Investigator to an IRB/IEC/REB. Approval from the IRB/IEC/REB must be obtained before starting the study and should be documented in a letter to the Investigator specifying the following: • Protocol number • Protocol version • Protocol date • Documents reviewed • Date on which the committee met and granted the approval‌ Any amendments to the protocol will require IRB/IEC/REB approval before implementation of changes made to the study design, unless local regulations or institutional policies require a longer retention periodexcept for changes necessary to eliminate an immediate hazard to study participants. No records may The Investigator will be destroyed during responsible for the retention period without the following: • Providing written approval summaries of the Sponsor. No records may be transferred to another location or party without written notification status of the study to the SponsorIRB/IEC/REB’s annually or more frequently in accordance with the requirements, policies, and procedures established by the IRB/IEC/REB • Notifying the IRB/IEC/REB of SAEs or other significant safety findings as required by procedures established by the IRB/IEC/REB.