Data Monitoring Committee Sample Clauses

Data Monitoring CommitteeNot applicable
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Data Monitoring CommitteeAn independent Data Monitoring Committee (DMC) will be implemented to detect possible xxxxx and to assure continuous risk/benefit assessment. A DMC is a group of independent experts external to the study assessing the progress, safety data and, if needed, critical efficacy endpoints. Details of the definition of DMC, its composition and its roles and responsibilities can be found in the separate DMC charter.
Data Monitoring Committee. (a) Unless otherwise agreed by the CSOG, clinical trials related to Clinical Studies will be overseen and the results reviewed by an independent Data Monitoring Committee (“DMC”) established and supported by Sponsor. The CSOG will review and approve the DMC’s membership and procedures. Sponsor will assume responsibility for setting up and supporting all DMC meetings. The CSOG will be notified of any DMC meetings. A representative from each party will be invited to attend all open sessions of the DMC meetings. All DMC open sessions reports related to a Clinical Study will be made available to the CSOG. (b) The CSOG will decide whether to accept or reject a major DMC recommendation for a clinical trial conducted at MSKCC under the Joint Clinical Development such as a recommendation to close a clinical trial related to a Clinical Study. Should the CSOG unanimously agree on accepting a major DMC recommendation, the CSOG will communicate that decision to the members of the DMC. Should the CSOG not unanimously agree on accepting or rejecting a major DMC recommendation, the dispute resolution process described in Section 2.4 will be followed. In the rare case when the CSOG does not elect to accept for implementation a major DMC recommendation, the CSOG will communicate that decision to the members of the DMC with an appropriate and clear rationale. For the avoidance of doubt, the DMC operates independent of this Agreement, and MSKCC has no obligation to continue any Clinical Study contrary to the recommendation of the DMC.
Data Monitoring Committee. A DMC will be appointed to review the study data and make recommendations concerning the continuation, modification, or termination of the study. The DMC will perform the following: • Scheduled evaluation of study conduct and progress and review of the cumulative safety and efficacy data. Scheduled meetings will take place as follows: - Kick off meeting before the first participant is enrolled - A meeting at the end of the first influenza season to review safety and efficacy data and perform a futility analysis (with re-powering if required), see Section 7.7.1 • Perform unscheduled review of data if one of the study pausing or holding rules is met, see Section 2.3 There will be a minimum of three appropriately qualified committee members of whom one will be the designated chair. The DMC will operate in accordance with the study-specific charter, which will be agreed prior to the start of enrolment. The chair of the DMC may be contacted for advice and independent review by the Investigator or Sponsor in any other situation where the Investigator or Sponsor feels independent advice or review is important. The DMC will be convened if any of the pausing or holding rules is met. The DMC will be notified within 24 hours of the Investigators’ being aware of any study treatment-related SAEs. The DMC has the power to place the study on hold if deemed necessary. If, following review of data by the DMC, a recommendation to resume study enrolment and vaccine administration is made, the DMC will record their judgment in a memorandum to the study file and notify the Sponsor. The DMC memorandum will be forwarded to the local Medical Monitor and Principal Investigators.
Data Monitoring Committee. The Parties may establish a data monitoring committee, of independent clinician(s) agreed to by the Parties, to make safety recommendations about the safety of the Study to the JDC.
Data Monitoring CommitteeNot Applicable
Data Monitoring Committee. There will not be a Data Monitoring Committee, but provision is included for an SRC (Section 9.7).
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Data Monitoring CommitteeAn independent DMC will review unblinded safety data throughout the study and make recommendations as appropriate. The DMC will begin data reviews approximately 3 months after the first patient is enrolled and continue quarterly reviews through the last dose of the last patient enrolled. The DMC will also evaluate available safety, tolerability, and efficacy data from the Phase 2 cohort prior to opening enrollment in the Phase 3 cohort. The DMC will consist of external experts supported by an independent statistical group which will prepare unblinded analyses for the DMC and will have no role in the statistical analysis plan (SAP) after the study has started enrolling patients. A separate, blinded statistical group (i.e., not associated with the DMC ) will be responsible for producing and finalizing the SAP and executing final data analysis of the study. The DMC will be governed by a charter that will describe the following: • Roles and responsibilities of the DMC members and the independent statistical group • Meeting format and frequencyCommunication channels between the DMC, the independent statistical group, the Sponsor, and the blinded study statisticians • Voting process and requirements (e.g., requirement of consensus for issuance of a termination recommendation) • Provisions governing conflict of interest and confidentiality Briefly, the DMC will review the progress of the study and the accumulating unblinded data while the study is ongoing. The DMC will make recommendations to Sponsor representatives following each meeting. The DMC may recommend that the study continue as is, be modified to protect patient safety, or be terminated. However, investigators, not the DMC, will make intra- patient dose-escalation decisions.
Data Monitoring Committee. Within [***] ([***]) working days after the Restated Effective Date, ARIAD and MERCK will send a letter jointly notifying the members of the SUCCEED Data Monitoring Committee of the change in IND ownership for Ridaforalimus and in the sponsorship of the SUCCEED Trial. MERCK shall thereafter submit the amended Charter of the Data Monitoring Committee for the SUCCEED Trial in the form agreed upon by the Parties contemporaneously with the execution hereof to the members of the Data Monitoring Committee, and upon their approval, submit the same to the FDA. Such amended Charter shall (i) designate MERCK as the trial sponsor, and (ii) replace ARIAD representatives to the Data Monitoring Committee with MERCK representatives. The Parties agree that no meeting of the Data Monitoring Committee for the SUCCEED Trial shall occur until such amendments of such Data Monitoring Committee’s charter have been completed. MERCK shall use Commercially Reasonable Efforts to provide ARIAD with at least [***] ([***]) days advance notice of any meeting of the Data Monitoring Committee for the SUCCEED Trial, and shall permit a senior representative of ARIAD to participate as an observer at all meetings of the Data Monitoring Committee for the SUCCEED Trial. In addition, MERCK shall (i) provide ARIAD copies of all significant correspondence with the Data Monitoring Committee for the SUCCEED Trial and any other Clinical Trial and each significant Regulatory Filing or other document or correspondence pertaining to any Product and submitted to the FDA or other Regulatory Authority and (ii) promptly provide ARIAD with copies of any significant document or other correspondence received from the Data Monitoring Committee for the SUCCEED Trial and any other Clinical Trial or the FDA pertaining to any Product. MERCK shall have the right to make all decisions with respect to recommendations of any Data Monitoring Committee and any responses to any such document or correspondence, but shall consider all comments of ARIAD in good faith. For purposes of this Section 3.9.4(c) Regulatory Filings, correspondence or documents shall be considered “significant” if such document could reasonably be expected to affect the likelihood or timing of obtaining Regulatory Approval, including Commercialization Regulatory Approval, or affect the label claims contained in Commercialization Regulatory Approval, or relate to the safety, efficacy or potency of the Licensed Product, or relate to regulatory complian...
Data Monitoring Committee. (a) Unless otherwise agreed by the COG, clinical trials related to Collaboration Projects will be overseen and the results reviewed by an independent Data Monitoring Committee (“DMC”) established and supported by Juno. The COG will review and approve the DMC’s membership and procedures. Juno will assume responsibility for setting up and supporting all DMC meetings. The COG will be notified of any DMC meetings. A representative from each party will be invited to attend all open sessions of the DMC meetings. All DMC open sessions reports related to a Collaboration Project will be made available to the COG. (b) The COG will decide whether to accept or reject a major DMC recommendation for a clinical trial conducted at FHCRC under the Collaboration such as a recommendation to close a clinical trial related to a Collaboration Project. Should the COG unanimously agree on accepting a major DMC recommendation, the COG will communicate that decision to the members of the DMC. Should the COG not unanimously agree on accepting or rejecting a major DMC recommendation, the dispute resolution process described in Section 2.4 will be followed. In the rare case when the COG does not elect to accept for implementation a major DMC recommendation, the COG will communicate that decision to the members of the DMC with an appropriate and clear rationale.
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