Common use of Clinical Data Management Clause in Contracts

Clinical Data Management. Data Management Project Team Due to the nature of the deliverables for this study, Omnicare CR has assumed a Clinical Data Leader (CDL) will be assigned to the Project for almost **** days per month for just over **** months. The LCDM will provide oversight of the management team as well as ensure that all deliverables are achieved. On a continual basis, the Omnicare CR team, CRAs, Project Leader/CTM and the CDL will work in concert, will evaluate number and type of queries being generated by Clinical Data Management, in order to proactively manage the retrieval of quality data for both the studies and site release status. Plans will be implemented to inspect the data for trends and issues in order to provide focused training at both the project team and the site levels. This will commence as soon as the first CRF pages are submitted in order to proactively resolve data issues. It is Omnicare CR’s policy to perform a quality control (QC) of the final database to ensure the error rate is within an acceptable range. Each CRF will be printed as a data listing with 100% QC of pre-defined critical data fields against the hard-copy CRF. In addition, a sampling of the patient data will undergo quality control for 100% of the data fields, prior to declaration of a clean database. The processes and outcomes of these QC audits will be documented, with audit findings corrected within the timeframe identified with the Data Management Plan. Omnicare CR supports the plan for transfer of clean data to give both Sponsor and the Omnicare CR Biometrics Group an opportunity to review clean data periodically, ensuring that guidelines are complete and accurate, and that the data is represented correctly in preparation for the analysis. Omnicare CR believes that these strategies will ensure: • Cleaner cases and data. • Minimises queries — assumption of one query every **** CRF pages. • Timely resolution of study and site issues. • Cohesiveness between Sponsor, Omnicare CR and the study site. **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. • On-time delivery of final clean clinical study database. • No surprises when preparing for data analysis. Data Management Plan (DMP) The DMP will include descriptions to the following Data Management activities: • Project data flow • Database development overview • Edit specifications • Data entry guidelines • Data handling guidelines • Study assumptions (Level 1) • SAE reconciliation process • External data load procedures / External Data Cleaning parameters / Discrepancy identification flow • Dictionary coding guidelines and processes • Database closure procedures Prior to the start of Data Management activities, the DMP and edit specifications must be agreed to and signed by the Omnicare CR designee and Sponsor representative. The agreement to all data handling rules will ensure an accurate and timely final database lock leading to a successful data analysis. It is assumed that all portions of the DMP related to any specific task will be agreed upon prior to the start of those activities. Review of Data Management Plan Omnicare CR assumes **** Sponsor review cycles including up to **** major and **** minor revision in order to finalize the DMP. CRF Design and CRF Completion Guidelines Omnicare CR assumes work on the CRF design will commence once the protocol is finalized. Upon receipt of the final draft comments, the final printable version of the CRF is prepared and provided to Sponsor for approval signature. The cost associated with this task will comprise of **** Sponsor review cycles with **** major and **** minor revision. The CRF completion guidelines will follow the same process as the CRF and will need to be finalized prior to commencement of study monitoring. Database Development Omnicare CR’s Data Management Department uses Oracle Clinical for a standardized, validated approach to database design, edit development, data collection and storage. Edit Checks The edit specifications identified in the DMP require Sponsor approval prior to the initiation of the programming of the edit checks (budget includes **** edits). It is Omnicare CR’s goal and in the project’s best interest to have all edits programmed and tested prior to any CRF data being **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. submitted to Data Management. This will ensure there are no delays in reviewing and querying the data. Omnicare CR suggests a periodic review of the edit specifications and data review guidelines to ensure that the rules and edit checks meet the project needs. Data Entry Omnicare CR assumes the CRFs for screen failure patients will not be received in-house, unless otherwise specified. All CRF and ancillary data received from the investigative Site are logged into a tracking database on a page-by-page basis. Each page is identified by type of page and date received. Working copies will be maintained in CDM and used for any annotations during processing and cleaning. All original (white) CRF and query pages will be immediately sent for filing in the Project Master File. Data Review and Query Processing Omnicare CR assumes that the study data will be received in TBD retrieval / retrievals per subject. Data review includes **** (****) manual review data checks and the application of **** (****) study assumptions for every **** (****) pages of the CRF per subject. Omnicare CR assumes that the manual review checks are not expected to exceed **** checks comparing **** datapoints.

Clinical Data Management. A Data Management Project Team Due to the nature of the deliverables for this study, Omnicare CR has assumed a Clinical Data Leader (CDL) team will be assigned to this project to carry out all of the Project for almost **** days per month for just over **** monthsactivities defined in the bid specifications. The LCDM team will provide oversight consist of a Lead Data Manager, Database Programming staff, Dictionary Manager and specialists, Clinical Data Analysts and Data Technicians. Team resources for the project will be developed by the Data Manager and will be based on the patient enrollment plan along with the Case Report Form retrieval plan. Adjustments will be made as needed as the study progress. The Data Management team will work together under the leadership of the management team as well as ensure that all deliverables are achieved. On a continual basis, the Omnicare CR team, CRAs, Project Leader/CTM and the CDL will work in concert, will evaluate number and type of queries being generated by Lead Clinical Data Management, in order to proactively manage the retrieval of quality data for both the studies and site release status. Plans will be implemented to inspect the data for trends and issues in order to provide focused training at both the project team and the site levels. This will commence as soon as the first CRF pages are submitted in order to proactively resolve data issues. It is Omnicare CR’s policy to perform a quality control (QC) of the final database Manager to ensure the error rate is within an acceptable range. Each CRF will be printed as meeting of all project quality deliverables along with a data listing with 100% QC of pre-defined critical data fields against the hard-copy CRF. In addition, a sampling of the patient data will undergo quality control for 100% of the data fields, prior to declaration of a clean database. The processes successful and outcomes of these QC audits will be documented, with audit findings corrected within the timeframe identified with the Data Management Plan. Omnicare CR supports the plan for transfer of clean data to give both Sponsor and the Omnicare CR Biometrics Group an opportunity to review clean data periodically, ensuring that guidelines are complete and accurate, and that the data is represented correctly in preparation for the analysis. Omnicare CR believes that these strategies will ensure: • Cleaner cases and data. • Minimises queries — assumption of one query every **** CRF pages. • Timely resolution of study and site issues. • Cohesiveness between Sponsor, Omnicare CR and the study sitetimely database closure. **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. • On-time delivery of final clean clinical study database. • No surprises when preparing for data analysis. Data Manager The Clinical Data Manager assigned to this project will oversee all Data Management Plan (DMP) The DMP activities throughout the life of the project. This dedicated Clinical Data Management will include descriptions to act as the following primary liaison for all Data Management activities. Many of the Clinical Data Management’s activities are listed bellow: • Project Overseeing the completion of setup and maintenance of all data flow management activities • Database development overview • Edit specifications • Data entry guidelines • Data handling guidelines • Study assumptions (Level 1) • SAE reconciliation process • External data load procedures / External Data Cleaning parameters / Discrepancy identification flow • Dictionary coding guidelines Creation and processes • Database closure procedures Prior to implementation of the start of Data Management activities, the DMP and edit specifications must be agreed to and signed by the Omnicare CR designee and Sponsor representativePlans. The agreement to all data handling rules Data Manager will ensure an accurate and timely final database lock leading to a successful data analysis. It is assumed that all portions of assure the DMP related to any specific task will be agreed upon prior to the start of those activities. Review of Data Management Plan Omnicare CR assumes **** Sponsor review cycles including up to **** major and **** minor revision in order to finalize the DMP. CRF Design and CRF Completion Guidelines Omnicare CR assumes work on the CRF design will commence once the protocol is finalized. Upon receipt of the final draft comments, the final printable version of the CRF is prepared and provided to Sponsor for approval signature. The cost associated with this task will comprise of **** Sponsor review cycles with **** major and **** minor revision. The CRF completion guidelines will follow the same process as the CRF and will need to be finalized prior to commencement of study monitoring. Database Development Omnicare CRSponsor’s Data Management Department uses Oracle Clinical for a standardized, validated approach to database design, edit development, data collection and storage. Edit Checks The edit specifications identified in the DMP require Sponsor approval prior to the initiation of any tasks outlined in this plan • Supporting the programming development of the edit checks (budget includes **** edits). It is CRF completion guidelines • Liaise with Clinical Trial Managers to ensure expectations for recording data accurately are communicated to the Project Team and the study site • Managing the query generation and final resolution • Proactively addressing data quality issues to reduce query generation • Liaise with the Clinical Trial Managers for timely query resolution • Ensuring high quality and timely data management deliverables • Maintain ongoing communication with Sponsor team members and Omnicare CR’s goal Project Team Members • Oversee Project training for Clinical Data Management team members • Provide status updates to both the Omnicare CR internal Project Team and the Sponsor team members • Clinical Data Management Project resource plan to ensure proper staffing throughout the study Lead Clinical Data Analyst Based on the deliverables for the Project, Omnicare CR has assigned a Lead Clinical Data Analyst. The Lead Clinical Data Analyst will provide additional team oversight for the Project Data Technicians and Clinical Data Analysts. The Lead Clinical Data Analyst will assist the Clinical Data Manager with the following activities in relation to the project’s best interest page-related staff: • Prioritization of Clinical Data Management tasks • Directing the daily Clinical Data Management team task assignments • Monitoring the status of task and work load • Ongoing Project training within Data Management • Providing feedback to have all edits programmed the Clinical Monitoring staff on query trends • Providing backup support to the Clinical Data Manager • Ensure a cohesive team that maintains high quality and tested prior to any CRF data being consistency • Generating metrics reports **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. submitted to Data Management. This will ensure there are no delays in reviewing and querying the data. Omnicare CR suggests a periodic review of the edit specifications and data review guidelines to ensure that the rules and edit checks meet the project needs. Data Entry Omnicare CR assumes the CRFs for screen failure patients will not be received in-house, unless otherwise specified. All CRF and ancillary data received from the investigative Site are logged into a tracking database on a page-by-page basis. Each page is identified by type of page and date received. Working copies will be maintained in CDM and used for any annotations during processing and cleaning. All original (white) CRF and query pages will be immediately sent for filing in the Project Master File. Data Review and Query Processing Omnicare CR assumes that the study data will be received in TBD retrieval / retrievals per subject. Data review includes **** (****) manual review data checks and the application of **** (****) study assumptions for every **** (****) pages of the CRF per subject. Omnicare CR assumes that the manual review checks are not expected to exceed **** checks comparing **** datapoints.

Clinical Data Management. Lead Clinical Data Management Project Team Analyst Due to the nature of the deliverables for this study, Omnicare CR has assumed a Lead Clinical Data Leader (CDL) Analyst will be assigned to the Project for almost **** days per month for just over **** monthsthis project. The LCDM Lead Clinical Data Analyst will provide oversight of oversee the data management team as well as ensure ensuring that all deliverables are achieved, with the support of the Data Manager. On a continual basis, the Data Management Plan Omnicare CR team, CRAs, Project Leader/CTM and the CDL will work in concert, will evaluate number and type of queries being generated by Clinical Data Management, in order to proactively manage the retrieval of quality data for both the studies and site release status. Plans will be implemented to inspect the data for trends and issues in order to provide focused training at both the project team and the site levels. This will commence as soon as the first CRF pages are submitted in order to proactively resolve data issues. It is Omnicare CR’s policy to perform a quality control (QC) of the final database to ensure the error rate is within an acceptable range. Each CRF will be printed as a data listing with 100% QC of pre-defined critical data fields against the hard-copy CRF. In addition, a sampling of the patient data will undergo quality control for 100% of the data fields, prior to declaration of a clean database. The processes and outcomes of these QC audits will be documented, with audit findings corrected within the timeframe identified with the Data Management Plan. Omnicare CR supports the plan for transfer of clean data to give both Sponsor and the Omnicare CR Biometrics Group an opportunity to review clean data periodically, ensuring that guidelines are complete and accurate, and that the data is represented correctly in preparation for the analysis. Omnicare CR believes that these strategies will ensure: • Cleaner cases and data. • Minimises queries — assumption of one query every assumes **** (****) Sponsor review cycles including up to **** (****) major and **** (****) minor revision in order to finalise the data management plan. If Sponsor requests Omnicare CR to begin work prior to a signed data management plan, the Clinical Data Manager will work with Sponsor’s representative. Changes to the data management plan (signed or unsigned) after the start of any work will incur a fee for rework and for any work going forward. CRF pagesDesign Omnicare CR assumes work on the CRF design will commence once the protocol is finalised. • Timely resolution The cost associated with this task is comprised **** (****) Sponsor review cycles with **** (****) major and **** (****) minor revision. If additional requests are made for modifications to the final approved CRF, Sponsor will be charged accordingly. The CRF completion guidelines will be prepared by Sponsor and will need to be finalised prior to commencement of study and site issuesmonitoring. • Cohesiveness between Sponsor, Database Development Omnicare CR and will develop the study siteclinical database utilising Oracle Clinical with Omnicare CR standard specifications. Should Sponsor request any changes to the post-production database structure, additional fees will be incurred. Edit Specifications Data review will be performed manually utilizing programmed data listings so no edits will be programmed. MedDRA and WHO-Drug Dictionaries Sponsor is required to have a current MedDRA and WHO-Drug license in good standing prior to receipt of any MedDRA or WHO-Drug coded terms. It is assumed under this Proposal that Sponsor has a current MedDRA and WHO-Drug license in good standing and that such will be maintained throughout the course of the study. **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. • On-time delivery of final clean clinical study database. • No surprises when preparing for data analysis. Data Management Plan (DMP) The DMP will include descriptions to the following Data Management activities: • Project data flow • Database development overview • Edit specifications • Data entry guidelines • Data handling guidelines • Study assumptions (Level 1) • SAE reconciliation process • External data load procedures / External Data Cleaning parameters / Discrepancy identification flow • Dictionary coding guidelines Review and processes • Database closure procedures Prior to the start of Data Management activities, the DMP and edit specifications must be agreed to and signed by the Omnicare CR designee and Sponsor representative. The agreement to all data handling rules will ensure an accurate and timely final database lock leading to a successful data analysis. It is assumed that all portions of the DMP related to any specific task will be agreed upon prior to the start of those activities. Query Processing Review of Data Management Plan Omnicare CR assumes **** Sponsor review cycles including up to **** major and **** minor revision in order to finalize the DMP. CRF Design and CRF Completion Guidelines Omnicare CR assumes work on the CRF design will commence once the protocol is finalized. Upon receipt of the final draft comments, the final printable version of the CRF is prepared and provided to Sponsor for approval signature. The cost associated with this task will comprise of **** Sponsor review cycles with **** major and **** minor revision. The CRF completion guidelines will follow the same process as the CRF and will need to be finalized prior to commencement of study monitoring. Database Development Omnicare CR’s Data Management Department uses Oracle Clinical for a standardized, validated approach to database design, edit development, data collection and storage. Edit Checks The edit specifications identified in the DMP require Sponsor approval prior to the initiation of the programming of the edit checks (budget includes **** edits). It is Omnicare CR’s goal and in the project’s best interest to have all edits programmed and tested prior to any CRF data being **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. submitted to Data Management. This will ensure there are no delays in reviewing and querying the data. Omnicare CR suggests a periodic review of the edit specifications and data review guidelines to ensure that the rules and edit checks meet the project needs. Data Entry Omnicare CR assumes the CRFs for screen failure patients will not be received in-house, unless otherwise specified. All CRF and ancillary data received from the investigative Site are logged into a tracking database on a page-by-page basis. Each page is identified by type of page and date received. Working copies will be maintained in CDM and used for any annotations during processing and cleaning. All original (white) CRF and query pages will be immediately sent for filing in the Project Master File. Data Review and Query Processing Omnicare CR assumes that the study data will be received in TBD retrieval / retrievals per subject. Data review includes **** (****) manual review data checks and the application of **** (****) study assumptions for every **** (****) pages of the CRF per subject. Omnicare CR assumes that the manual review checks are not expected to exceed **** checks comparing **** datapoints. Should the manual review checks exceed **** checks, Sponsor will be billed for actuals. Data Management Reports Omnicare CR will provide Sponsor its standard CRF and DCF reports on a monthly basis.The standard reports consist of cumulative CRF/DCF status; cumulative CRF by site; outstanding DCFs by site; resolved DCFs by site and weekly metrics (data processing). Custom metrics and data reports are available for an additional fee. Protocol Deviation Log Load Omnicare CR will develop an additional Oracle Clinical module in order to load Sponsor’s log of protocol deviations into the clinical database. This includes development of the DCM/DCI module, loading the spreadsheet database, and quality control of received data.

Clinical Data Management. A Data Management Project Team Due to the nature of the deliverables for this study, Omnicare CR has assumed a Clinical Data Leader (CDL) team will be assigned to this project to carry out all of the Project for almost **** days per month for just over **** monthsactivities defined in the bid specifications. The LCDM team will provide oversight consist of a Lead Data Manager, Database Programming staff, Dictionary Manager and specialists, Clinical Data Analysts and Data Technicians. Team resources for the project will be developed by the Data Manager and will be based on the patient enrollment plan along with the Case Report Form retrieval plan. Adjustments will be made as needed as the study progress. The Data Management team will work together under the leadership of the management team as well as ensure that all deliverables are achieved. On a continual basis, the Omnicare CR team, CRAs, Project Leader/CTM and the CDL will work in concert, will evaluate number and type of queries being generated by Lead Clinical Data Management, in order to proactively manage the retrieval of quality data for both the studies and site release status. Plans will be implemented to inspect the data for trends and issues in order to provide focused training at both the project team and the site levels. This will commence as soon as the first CRF pages are submitted in order to proactively resolve data issues. It is Omnicare CR’s policy to perform a quality control (QC) of the final database Manager to ensure the error rate is within an acceptable range. Each CRF will be printed as meeting of all project quality deliverables along with a data listing with 100% QC of pre-defined critical data fields against the hard-copy CRF. In addition, a sampling of the patient data will undergo quality control for 100% of the data fields, prior to declaration of a clean database. The processes successful and outcomes of these QC audits will be documented, with audit findings corrected within the timeframe identified with the Data Management Plan. Omnicare CR supports the plan for transfer of clean data to give both Sponsor and the Omnicare CR Biometrics Group an opportunity to review clean data periodically, ensuring that guidelines are complete and accurate, and that the data is represented correctly in preparation for the analysis. Omnicare CR believes that these strategies will ensure: • Cleaner cases and data. • Minimises queries — assumption of one query every **** CRF pages. • Timely resolution of study and site issues. • Cohesiveness between Sponsor, Omnicare CR and the study sitetimely database closure. **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 24b-2 of the Securities Exchange Act of 19331934, as amended. • On-time delivery of final clean clinical study database. • No surprises when preparing for data analysis. Data Manager The Clinical Data Manager assigned to this project will oversee all Data Management Plan (DMP) The DMP activities throughout the life of the project. This dedicated Clinical Data Management will include descriptions to act as the following primary liaison for all Data Management activities. Many of the Clinical Data Management’s activities are listed bellow: • Project Overseeing the completion of setup and maintenance of all data flow management activities • Database development overview • Edit specifications • Data entry guidelines • Data handling guidelines • Study assumptions (Level 1) • SAE reconciliation process • External data load procedures / External Data Cleaning parameters / Discrepancy identification flow • Dictionary coding guidelines Creation and processes • Database closure procedures Prior to implementation of the start of Data Management activities, the DMP and edit specifications must be agreed to and signed by the Omnicare CR designee and Sponsor representativePlans. The agreement to all data handling rules Data Manager will ensure an accurate and timely final database lock leading to a successful data analysis. It is assumed that all portions of assure the DMP related to any specific task will be agreed upon prior to the start of those activities. Review of Data Management Plan Omnicare CR assumes **** Sponsor review cycles including up to **** major and **** minor revision in order to finalize the DMP. CRF Design and CRF Completion Guidelines Omnicare CR assumes work on the CRF design will commence once the protocol is finalized. Upon receipt of the final draft comments, the final printable version of the CRF is prepared and provided to Sponsor for approval signature. The cost associated with this task will comprise of **** Sponsor review cycles with **** major and **** minor revision. The CRF completion guidelines will follow the same process as the CRF and will need to be finalized prior to commencement of study monitoring. Database Development Omnicare CRSponsor’s Data Management Department uses Oracle Clinical for a standardized, validated approach to database design, edit development, data collection and storage. Edit Checks The edit specifications identified in the DMP require Sponsor approval prior to the initiation of any tasks outlined in this plan • Supporting the programming development of the edit checks (budget includes **** edits). It is CRF completion guidelines • Liaise with Clinical Trial Managers to ensure expectations for recording data accurately are communicated to the Project Team and the study site • Managing the query generation and final resolution • Proactively addressing data quality issues to reduce query generation • Liaise with the Clinical Trial Managers for timely query resolution • Ensuring high quality and timely data management deliverables • Maintain ongoing communication with Sponsor team members and Omnicare CR’s goal Project Team Members • Oversee Project training for Clinical Data Management team members • Provide status updates to both the Omnicare CR internal Project Team and the Sponsor team members • Clinical Data Management Project resource plan to ensure proper staffing throughout the study Lead Clinical Data Analyst Based on the deliverables for the Project, Omnicare CR has assigned a Lead Clinical Data Analyst. The Lead Clinical Data Analyst will provide additional team oversight for the Project Data Technicians and Clinical Data Analysts. The Lead Clinical Data Analyst will assist the Clinical Data Manager with the following activities in relation to the project’s best interest page-related staff: • Prioritization of Clinical Data Management tasks • Directing the daily Clinical Data Management team task assignments • Monitoring the status of task and work load • Ongoing Project training within Data Management • Providing feedback to have all edits programmed the Clinical Monitoring staff on query trends • Providing backup support to the Clinical Data Manager • Ensure a cohesive team that maintains high quality and tested prior to any CRF data being consistency • Generating metrics reports **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 24b-2 of the Securities Exchange Act of 19331934, as amended. submitted to Data Management. This will ensure there are no delays in reviewing and querying the data. Omnicare CR suggests a periodic review of the edit specifications and data review guidelines to ensure that the rules and edit checks meet the project needs. Data Entry Omnicare CR assumes the CRFs for screen failure patients will not be received in-house, unless otherwise specified. All CRF and ancillary data received from the investigative Site are logged into a tracking database on a page-by-page basis. Each page is identified by type of page and date received. Working copies will be maintained in CDM and used for any annotations during processing and cleaning. All original (white) CRF and query pages will be immediately sent for filing in the Project Master File. Data Review and Query Processing Omnicare CR assumes that the study data will be received in TBD retrieval / retrievals per subject. Data review includes **** (****) manual review data checks and the application of **** (****) study assumptions for every **** (****) pages of the CRF per subject. Omnicare CR assumes that the manual review checks are not expected to exceed **** checks comparing **** datapoints.

Clinical Data Management. Data Management Project Team Due to the nature of the deliverables for this study, Omnicare CR has assumed a Clinical Data Leader (CDL) will be assigned to the Project for almost **** days per month for just over **** months. The LCDM will provide oversight of the management team as well as ensure that all deliverables are achieved. On a continual basis, the Omnicare CR team, CRAs, Project Leader/CTM and the CDL will work in concert, will evaluate number and type of queries being generated by Clinical Data Management, in order to proactively manage the retrieval of quality data for both the studies and site release status. Plans will be implemented to inspect the data for trends and issues in order to provide focused training at both the project team and the site levels. This will commence as soon as the first CRF pages are submitted in order to proactively resolve data issues. It is Omnicare CR’s policy to perform a quality control (QC) of the final database to ensure the error rate is within an acceptable range. Each CRF will be printed as a data listing with 100% QC of pre-defined critical data fields against the hard-copy CRF. In addition, a sampling of the patient data will undergo quality control for 100% of the data fields, prior to declaration of a clean database. The processes and outcomes of these QC audits will be documented, with audit findings corrected within the timeframe identified with the Data Management Plan. Omnicare CR supports the plan for transfer of clean data to give both Sponsor and the Omnicare CR Biometrics Group an opportunity to review clean data periodically, ensuring that guidelines are complete and accurate, and that the data is represented correctly in preparation for the analysis. Omnicare CR believes that these strategies will ensure: • Cleaner cases and data. • Minimises queries — assumption of one query every **** CRF pages. • Timely resolution of study and site issues. • Cohesiveness between Sponsor, Omnicare CR and the study site. **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 24b-2 of the Securities Exchange Act of 19331934, as amended. • On-time delivery of final clean clinical study database. • No surprises when preparing for data analysis. Data Management Plan (DMP) The DMP will include descriptions to the following Data Management activities: • Project data flow • Database development overview • Edit specifications • Data entry guidelines • Data handling guidelines • Study assumptions (Level 1) • SAE reconciliation process • External data load procedures / External Data Cleaning parameters / Discrepancy identification flow • Dictionary coding guidelines and processes • Database closure procedures Prior to the start of Data Management activities, the DMP and edit specifications must be agreed to and signed by the Omnicare CR designee and Sponsor representative. The agreement to all data handling rules will ensure an accurate and timely final database lock leading to a successful data analysis. It is assumed that all portions of the DMP related to any specific task will be agreed upon prior to the start of those activities. Review of Data Management Plan Omnicare CR assumes **** Sponsor review cycles including up to **** major and **** minor revision in order to finalize the DMP. CRF Design and CRF Completion Guidelines Omnicare CR assumes work on the CRF design will commence once the protocol is finalized. Upon receipt of the final draft comments, the final printable version of the CRF is prepared and provided to Sponsor for approval signature. The cost associated with this task will comprise of **** Sponsor review cycles with **** major and **** minor revision. The CRF completion guidelines will follow the same process as the CRF and will need to be finalized prior to commencement of study monitoring. Database Development Omnicare CR’s Data Management Department uses Oracle Clinical for a standardized, validated approach to database design, edit development, data collection and storage. Edit Checks The edit specifications identified in the DMP require Sponsor approval prior to the initiation of the programming of the edit checks (budget includes **** edits). It is Omnicare CR’s goal and in the project’s best interest to have all edits programmed and tested prior to any CRF data being **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 24b-2 of the Securities Exchange Act of 19331934, as amended. submitted to Data Management. This will ensure there are no delays in reviewing and querying the data. Omnicare CR suggests a periodic review of the edit specifications and data review guidelines to ensure that the rules and edit checks meet the project needs. Data Entry Omnicare CR assumes the CRFs for screen failure patients will not be received in-house, unless otherwise specified. All CRF and ancillary data received from the investigative Site are logged into a tracking database on a page-by-page basis. Each page is identified by type of page and date received. Working copies will be maintained in CDM and used for any annotations during processing and cleaning. All original (white) CRF and query pages will be immediately sent for filing in the Project Master File. Data Review and Query Processing Omnicare CR assumes that the study data will be received in TBD retrieval / retrievals per subject. Data review includes **** (****) manual review data checks and the application of **** (****) study assumptions for every **** (****) pages of the CRF per subject. Omnicare CR assumes that the manual review checks are not expected to exceed **** checks comparing **** datapoints.