Common use of Feasibility Queries Clause in Contracts

Feasibility Queries. (a) The Affiliate Investigator will submit to the GPC Administrative Site a fully-executed GPC System Access Agreement, a template of which is attached as Exhibit C, which will prohibit the downloading, printing, or retaining of the Aggregate Response obtained as a result of the Feasibility Query, prohibit use of the Aggregate Response for any purpose other than determining the feasibility of a potential Research Project, and require the conduct of the cohort identification in a responsible manner and in compliance with applicable laws. (b) Upon the GPC Administrative Site’s receipt and processing of the GPC System Access Agreement, the Affiliate Investigator may submit a Proposed Feasibility Query, via a request management system to the DROC for review. The Proposed Feasibility Query will include a list of requested GPC Parties. DROC representatives will first review the Proposed Feasibility Query for alignment with the goals of, and suitability for, the GPC generally. If the Feasibility Query is approved, then each GPC Party (following its own internal approval process) will determine if it wishes to accept the request. GPC Parties may only Accept Feasibility Queries which are Approved by the DROC. Any GPC Party may refuse to Accept any Feasibility Query in which it does not want to participate. (c) Upon completion of the review process described in the previous paragraph, the Honest Broker for each accepting GPC Party will query its Research Repository and submit the requested information (in the form of De-Identified Information) to the designated GPC Honest Broker. The GPC Honest Broker will create the Aggregate Response for use in accordance with the GPC System Access Agreement. The Aggregate Response will be stored on GPC Hosted Services, and will be available on a REDCap data base with attached files for retrieval by the Affiliate Investigator. (d) The Affiliate Investigator will submit a valid user name and password to gain access to the GPC Hosted Services hosting the Aggregate Response. (e) To prevent inadvertent identification of patients, information for sample sizes of fewer than ten (10) patients will not be provided.

Feasibility Queries. (ai) The Affiliate Investigator Data Requestor will submit to the GPC Administrative Site a fully-executed GPC System Access Agreement, a template of which is attached as Exhibit C, which will prohibit the downloading, printing, or retaining of the Aggregate Response obtained as a result of the Feasibility Query, prohibit use of the Aggregate Response for any purpose other than determining the feasibility of a potential Research Project, and require the conduct of the cohort identification in a responsible manner and in compliance with applicable laws.. A copy of the GPC System Access Agreement is set forth as Exhibit A. (bii) Upon the GPC Administrative Site’s receipt and processing of the GPC System Access Agreement, the Affiliate Investigator Data Requestor may submit a Proposed Feasibility Query, via a request management system to be determined and configured by the GPC Administrative Site, to the DROC for reviewreview in accordance with Section 4.01. The Proposed Feasibility Query will include a list of requested GPC PartiesRequested Participants. DROC representatives will first review in good faith the Proposed Feasibility Query for alignment with the goals of, and suitability for, the GPC generally. If the Feasibility Query is approvedApproved by a majority vote of a Quorum of DROC representatives, then each GPC Party Participant (following its own internal approval process) will determine if it the Participant wishes to accept the requestAccept it. GPC Parties Participants may only not Accept any Feasibility Queries Query which are Approved by the DROCis not Approved. Any GPC Party Participant may refuse to Accept any Feasibility Query in which it does not want to participate. (ciii) Upon completion of the review process described in the previous paragraph, the Participant Honest Broker for each accepting GPC Party Accepting Participant will query its Research Repository as directed by the Approved Feasibility Query and submit the requested information Information (in the form of De-Identified Information) to the designated GPC Honest Broker. The GPC Honest Broker will create the Aggregate Response for use in accordance with the GPC System Access Agreement. The Aggregate Response will be stored on GPC Hosted Services, and will be available on a REDCap data base with attached files for retrieval by the Affiliate InvestigatorData Requestor. (div) The Affiliate Investigator Data Requestor 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. (ev) To prevent inadvertent identification of patients, information Information for sample sizes of fewer than ten (10) patients will not be providedprovided to the Data Requestor.

Feasibility Queries. (a) The Affiliate Investigator will submit to the GPC Administrative Site a fully-fully- executed GPC System Access Agreement, a template of which is attached as Exhibit CB , which will prohibit the downloading, printing, or retaining of the Aggregate Response obtained as a result of the Feasibility Query, prohibit use of the Aggregate Response for any purpose other than determining the feasibility of a potential Research Project, and require the conduct of the cohort identification in a responsible manner and in compliance with applicable laws. (b) Upon the GPC Administrative Site’s receipt and processing of the GPC System Access Agreement, the Affiliate Investigator may submit a Proposed Feasibility Query, via a request management system to the DROC for review. The Proposed Feasibility Query will include a list of requested GPC Parties. DROC representatives will first review the Proposed Feasibility Query for alignment with the goals of, and suitability for, the GPC generally. If the Feasibility Query is approved, then each GPC Party (following its own internal approval process) will determine if it wishes to accept the request. GPC Parties may only Accept Feasibility Queries which are Approved by the DROC. Any GPC Party may refuse to Accept any Feasibility Query in which it does not want to participate. (c) Upon completion of the review process described in the previous paragraph, the Honest Broker for each accepting GPC Party will query its Research Repository and submit the requested information (in the form of De-Identified Information) to the designated GPC Honest Broker. The GPC Honest Broker will create the Aggregate Response for use in accordance with the GPC System Access Agreement. The Aggregate Response will be stored on GPC Hosted Services, and will be available on a REDCap data base datab as e with attached files for retrieval by the Affiliate Investigator. (d) The Affiliate Investigator will submit a valid user name and password to gain access to the GPC Hosted Services hosting the Aggregate Response. (e) To prevent inadvertent identification of patients, information for sample sizes of fewer than ten (10) patients will not be provided.

Feasibility Queries. (ai) The Affiliate Investigator Data Requestor will submit to the GPC Administrative Site a fully-executed GPC System Access Agreement, a template of which is attached as Exhibit C, which will prohibit the downloading, printing, or retaining of the Aggregate Response obtained as a result of the Feasibility Query, prohibit use of the Aggregate Response for any purpose other than determining the feasibility of a potential Research Project, and require the conduct of the cohort identification in a responsible manner and in compliance with applicable laws.. A copy of the GPC System Access Agreement is set forth as Exhibit A. (bii) Upon the GPC Administrative Site’s receipt and processing of the GPC System Access Agreement, the Affiliate Investigator Data Requestor may submit a Proposed Feasibility Query, via a request management system to be determined and configured by the GPC Administrative Site, to the DROC for reviewreview in accordance with Section 4.01. The Proposed Feasibility Query will include a list of requested GPC PartiesRequested Participants. DROC representatives will first review in good faith the Proposed Feasibility Query for alignment with the goals of, and suitability for, the GPC generally. If the Feasibility Query is approvedApproved by a majority vote of a Quorum of DROC representatives, then each GPC Party Participant (following its own internal approval process) will determine if it the Participant wishes to accept the requestAccept it. GPC Parties Participants may only not Accept any Feasibility Queries Query which are Approved by the DROCis not Approved. Any GPC Party Participant may refuse to Accept any Feasibility Query in which it does not want to participate. Consistent with paragraph 4.02 (f) below, when the Parties develop a process to allow Data Requestors to directly perform Feasibility Queries using open-source software configured by KUMC, such Feasibility Queries will not require DROC review and approval. (ciii) Upon completion of the review process described in the previous paragraph, the Participant Honest Broker for each accepting GPC Party Accepting Participant will query its Research Repository as directed by the Approved Feasibility Query and submit the requested information Information (in the form of De-Identified Information) to the designated GPC Honest Broker. The GPC Honest Broker will create the Aggregate Response for use in accordance with the GPC System Access Agreement. The Aggregate Response will be stored on GPC Hosted Services, and will be available on a REDCap data base with attached files for retrieval by the Affiliate InvestigatorData Requestor. (div) The Affiliate Investigator Data Requestor 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. (e) To prevent inadvertent identification of patients, information for sample sizes of fewer than ten (10) patients will not be provided.