Common use of Research Projects Clause in Contracts

Research Projects. (a) The Affiliate Investigator may submit a Proposed Research Project via the GPC request management system to the DROC for review. The Proposed Research Project will include, at a minimum: a list of requested GPC Parties; a detailed protocol; documentation of IRB approval and waiver, if necessary, if the protocol design so requires (IRB approval will not be required for Research Projects requesting only De-identified Information); and the identity of any other entities supporting the Research Project, whether by funding, study drug support, or otherwise and the amount of such support. (b) The DROC will first review the Proposed Research Project for alignment with the goals of, and suitability for, the GPC generally. DROC representatives may request additional information from the Affiliate Investigator, at any time to aid in its review. If the Proposed Research Project is approved, a DROC representative from each requested GPC Party will then review it pursuant to its own internal approval process, to determine if it wishes to accept the request. GPC Parties may not Accept any Research Project which is not approved by the DROC. Any GPC Party may refuse to Accept any Research Project in which it does not want to participate. (c) The GPC Administrative Site will notify the Affiliate Investigator upon Approval of the Proposed Research Project and provide a list of accepting GPC Parties. If the Affiliate Investigator wishes to proceed, regardless of whether the GPC Data requested is De-identified GPC Data or a Limited Data Set, the Affiliate Investigator will be required to submit to the GPC Administrative Site an executed GPC Data Use Agreement (see Exhibit D) prior to being permitted to access the Aggregate Response. (d) Upon completion of the review and contracting processes described in the preceding paragraphs, and the collection of prospective data if applicable, each Honest Broker for each accepting GPC Party will query its Research Repository as directed by the Approved Research Project and submit the information in the agreed upon format to the GPC Honest Broker. (e) The GPC Honest Broker will create the Aggregate Response for use in accordance with the Data Use Agreement and any other agreements which may apply to the Approved Research Project. The Aggregate Response will be stored on the GPC Hosted Services, and will be available on a REDCap data base with attached files for retrieval by the Affiliate Investigator. (f) The Affiliate Investigator of the Approved Research Project will submit a valid user name and password to gain access to the GPC Hosted Services hosting the Aggregate Response. (g) To prevent inadvertent identification of patients, De-Identified Information for sample sizes of fewer than ten (10) patients will not be provided to an Affiliate Investigator.

Research Projects. (a) The Affiliate Investigator may submit a Proposed Research Project via the GPC request management system to the DROC for review. The Proposed Research Project will include, at a minimum: a list of requested GPC Parties; a detailed protocol; documentation of IRB approval and waiver, if necessary, if the protocol design so requires (IRB approval will not be required for Research Projects requesting only De-identified Information); and the identity of any other entities supporting the Research Project, whether by funding, study drug support, or otherwise and the amount of such support. (b) The DROC will first review the Proposed Research Project for alignment with the goals of, and suitability for, the GPC generally. DROC representatives may request additional information from the Affiliate Investigator, at any time to aid in its review. If the Proposed Research Project is approved, a DROC representative from each requested GPC Party will would then review it pursuant to its own internal approval process, to determine if it wishes to accept the request. GPC Parties may not Accept any Research Project which is not approved by the DROC. Any GPC Party may refuse to Accept any Research Project in which it does not want to participate. (c) The GPC Administrative Site will notify the Affiliate Investigator upon Approval of the Proposed Research Project and provide a list of accepting GPC Parties. If the Affiliate Investigator wishes to proceed, regardless of whether the GPC Data requested is De-identified GPC Data or a Limited Data Set, the Affiliate Investigator will be required to submit to the GPC Administrative Site an executed GPC Data Transfer and Use Agreement (see Exhibit DC) prior to being permitted to access the Aggregate Response. (d) Upon completion of the review and contracting processes described in the preceding paragraphs, and the collection of prospective data if applicable, each Honest Broker for each accepting GPC Party will query its Research Repository as directed by the Approved Research Project and submit the information in the agreed upon format to the GPC Honest Broker. (e) The GPC Honest Broker will create the Aggregate Response for use in accordance with the Data Transfer and Use Agreement and any other agreements which may apply to the Approved Research Project. The Aggregate Response will be stored on the GPC Hosted Services, and will be available on a REDCap data base database with attached files for retrieval by the Affiliate Investigator. (f) The Affiliate Investigator of the Approved Research Project will submit a valid user name and password to gain access to the GPC Hosted Services hosting the Aggregate Response. (g) To prevent inadvertent identification of patients, De-Identified Information for sample sizes of fewer than ten (10) patients will not be provided to an Affiliate Investigator.

Research Projects. (ai) The Affiliate Investigator Data Requestor may submit a Proposed Research Project via the GPC a request management system to be determined and configured by GPC Administrative Site to the DROC for reviewreview in accordance with Section 4.01. The Proposed Research Project will include, at a minimum: a list of requested GPC PartiesRequested Participants; a detailed protocol; documentation of IRB approval and waiver, if necessary, if the protocol design so requires (IRB approval will not be required for Research Projects requesting only De-identified Information); and the identity of any other entities supporting the Research Project, whether by funding, study drug support, or otherwise and the amount of such support. (bii) The DROC will first review the Proposed Research Project for alignment with the goals of, and suitability for, the GPC generally. DROC representatives may request additional information from the Affiliate InvestigatorData Requestor, at any time to aid in its review. If the Proposed Research Project is approvedApproved by a majority vote of a Quorum of DROC representatives, a DROC representative from each requested GPC Party Requested Participant will then review it pursuant to its that Participant’s own internal approval process, to determine if it such Participant wishes to accept the requestAccept it. GPC Parties Participants may not Accept any Research Project which is not approved Approved by the DROC. Any GPC Party Participant may refuse to Accept any Research Project in which it does not want to participate. (ciii) The GPC Administrative Site will notify the Affiliate Investigator Data Requestor upon Approval of the Proposed Research Project and provide a list of accepting GPC PartiesAccepting Participants. If the Affiliate Investigator Data Requestor wishes to proceed, regardless of whether the GPC Data Information requested is De-identified GPC Data or a Limited Data Set, the Affiliate Investigator Data Requestor will be required to submit to the GPC Administrative Site an executed GPC Data Use Agreement (see Exhibit D) naming and all Accepting Participants as parties prior to being permitted to access the Aggregate Response. A copy of the GPC Data Use Agreement is set forth as Exhibit B. (iv) The Participants acknowledge that some Approved Research Projects may require additional agreements, such as clinical trial agreements, depending on factors such as the protocol design and the conditions of any supporting entities. Each Participant acknowledges that by its Acceptance of an Approved Research Project, it agrees to provide the administrative resources necessary to negotiate such agreements. Each Participant further agrees that it will not release any Information (in the form of either De-Identified Information or a Limited Data Set) for an Approved Research Project to the GPC or Data Requestor unless and until all necessary agreements are fully executed. (dv) Upon completion of the review and contracting processes described in the preceding paragraphs, and the collection of prospective data if applicable, each the Participant Honest Broker for each accepting GPC Party Accepting Participant will query its Research Repository as directed by the Approved Research Project and submit the information Information in the agreed upon format to the GPC Honest Broker. (evi) The GPC Honest Broker will create the Aggregate Response for use in accordance with the Data Use Agreement and any other agreements which may apply to the Approved Research Project. The Aggregate Response will be stored on the GPC Hosted Services, and will be available on a REDCap data base with attached files for retrieval by the Affiliate InvestigatorData Requestor. (fvii) The Affiliate Investigator Data Requestor of the Approved Research Project will submit a valid user name and password to gain access to the GPC Hosted Services hosting the Aggregate Response. Each session will be logged by the GPC Hosted Services for review by the DROC as desired. (g) To prevent inadvertent identification of patients, De-Identified Information for sample sizes of fewer than ten (10) patients will not be provided to an Affiliate Investigator.

Research Projects. (ai) The Affiliate Investigator Data Requestor may submit a Proposed Research Project via the GPC a request management system to be determined and configured by GPC Administrative Site to the DROC for reviewreview in accordance with Section 4.01. The Proposed Research Project will include, at a minimum: a list of requested GPC PartiesRequested Participants; a detailed protocol; documentation of IRB approval and waiver, if necessary, if the protocol design so requires (IRB approval will not be required for Research Projects requesting only De-identified Information); and the identity of any other entities supporting the Research Project, whether by funding, study drug support, or otherwise and the amount of such support. (bii) The DROC will first review the Proposed Research Project for alignment with the goals of, and suitability for, the GPC generally. DROC representatives may request additional information from the Affiliate InvestigatorData Requestor, at any time to aid in its review. If the Proposed Research Project is approvedApproved by a majority vote of a Quorum of DROC representatives, a DROC representative from each requested GPC Party Requested Participant will then review it pursuant to its that Participant’s own internal approval process, to determine if it such Participant wishes to accept the requestAccept it. GPC Parties Participants may not Accept any Research Project which is not approved Approved by the DROC. Any GPC Party Participant may refuse to Accept any Research Project in which it does not want to participate. (ciii) The GPC Administrative Site will notify the Affiliate Investigator Data Requestor upon Approval of the Proposed Research Project and provide a list of accepting GPC PartiesAccepting Participants. If the Affiliate Investigator Data Requestor wishes to proceed, regardless of whether the GPC Data Information requested is De-identified GPC Data or Information, a Limited Data SetSet or Identifiable Data, the Affiliate Investigator Data Requestor will be required to submit to the GPC Administrative Site an executed GPC Data Use Agreement (see Exhibit D) naming KUMC and all Accepting Participants as parties prior to being permitted to access the Aggregate Response. A copy of the GPC Data Use Agreement is set forth as Exhibit B. (iv) The Participants acknowledge that some Approved Research Projects may require additional agreements, such as clinical trial agreements, depending on factors such as the protocol design and the conditions of any supporting entities. Each Participant acknowledges that by its Acceptance of an Approved Research Project, it agrees to provide the administrative resources necessary to negotiate such agreements. Each Participant further agrees that it will not release any Information (in the form of De-Identified Information, a Limited Data Set, or Identifiable Data) for an Approved Research Project to the GPC or Data Requestor unless and until all necessary agreements are fully executed. (dv) Upon completion of the review and contracting processes described in the preceding paragraphs, and the collection of prospective data if applicable, each the Participant Honest Broker for each accepting GPC Party Accepting Participant will query its Research Repository as directed by the Approved Research Project and submit the information Information in the agreed upon format to the GPC Honest Broker. (evi) The GPC Honest Broker will create the Aggregate Response for use in accordance with the Data Use Agreement and any other agreements which may apply to the Approved Research Project. The Aggregate Response will be stored on the GPC Hosted Services, and will be available on a REDCap data base with attached files for retrieval by the Affiliate InvestigatorData Requestor. (fvii) The Affiliate Investigator Data Requestor of the Approved Research Project will submit a valid user name and password to gain access to the GPC Hosted Services hosting the Aggregate Response. Each session will be logged by the GPC Hosted Services for review by the DROC as desired. (g) To prevent inadvertent identification of patients, De-Identified Information for sample sizes of fewer than ten (10) patients will not be provided to an Affiliate Investigator.

Research Projects. (a) The Affiliate Investigator Data Requestor may submit a Proposed Research Project via the GPC a request management system to be determined and configured by GPC Administrative Site to the DROC for reviewreview in accordance with Section IV.1. The Proposed Research Project will include, at a minimum: a list of requested GPC PartiesRequested Participants; a detailed protocol; documentation of IRB approval and waiver, if necessary, if the protocol design so requires (IRB approval will not be required for Research Projects requesting only De-identified Information); and the identity of any other entities supporting the Research Project, whether by funding, study drug support, or otherwise and the amount of such support. (b) . The DROC will first review the Proposed Research Project for alignment with the goals of, and suitability for, the GPC generally. DROC representatives may request additional information from the Affiliate InvestigatorData Requestor, at any time to aid in its review. If the Proposed Research Project is approvedApproved by a majority vote of a Quorum of DROC representatives, a DROC representative from each requested GPC Party Requested Participant will then review it pursuant to its that Participant’s own internal approval process, to determine if it such Participant wishes to accept the requestAccept it. GPC Parties Participants may not Accept any Research Project which is not approved Approved by the DROC. Any GPC Party Participant may refuse to Accept any Research Project in which it does not want to participate. (c) . The GPC Administrative Site will notify the Affiliate Investigator Data Requestor upon Approval of the Proposed Research Project and provide a list of accepting GPC PartiesAccepting Participants. If the Affiliate Investigator Data Requestor wishes to proceed, regardless of whether the GPC Data Information requested is De-identified GPC Data or a Limited Data Set, the Affiliate Investigator Data Requestor will be required to submit to the GPC Administrative Site an executed GPC Data Use Agreement (see Exhibit D) naming KUMC and all Accepting Participants as parties prior to being permitted to access the Aggregate Response. . A copy of the GPC Data Use Agreement is set forth as Exhibit B. The Participants acknowledge that some Approved Research Projects may require additional agreements, such as clinical trial agreements, depending on factors such as the protocol design and the conditions of any supporting entities. Each Participant acknowledges that by its Acceptance of an Approved Research Project, it agrees to provide the administrative resources necessary to negotiate such agreements. Each Participant further agrees that it will not release any Information (din the form of either De-Identified Information or a Limited Data Set) for an Approved Research Project to the GPC or Data Requestor unless and until all necessary agreements are fully executed. Upon completion of the review and contracting processes described in the preceding paragraphs, and the collection of prospective data if applicable, each the Participant Honest Broker for each accepting GPC Party Accepting Participant will query its Research Repository as directed by the Approved Research Project and submit the information Information in the agreed upon format to the GPC Honest Broker. (e) . The GPC Honest Broker will create the Aggregate Response for use in accordance with the Data Use Agreement and any other agreements which may apply to the Approved Research Project. The Aggregate Response will be stored on the GPC Hosted Services, and will be available on a REDCap data base with attached files for retrieval by the Affiliate Investigator. (f) Data Requestor. The Affiliate Investigator Data Requestor of the Approved Research Project will submit a valid user name and password to gain access to the GPC Hosted Services hosting the Aggregate Response. (g) . Each session will be logged by the GPC Hosted Services for review by the DROC as desired. To prevent inadvertent identification of patients, De-Identified Information for sample sizes of fewer than ten (10) patients will not be provided to an Affiliate Investigator.the Data Requestor..