Protocol Amendments. There will be no alteration to the protocol without the express written approval of the Sponsor. The local authorities or ethics committees must approve all major protocol amendments prior to implementation. No protocol amendments should be adopted without prior written approval from the ethics committee except in the following cases: · in order to eliminate immediate hazard to the patients, · changes involving only logistical or administrative aspects of the trial. Then notification to the relevant authorities should be submitted. In these cases, the implemented deviation or change should be submitted as soon as possible to the relevant authorities for review and approval. No protocol deviations are anticipated. However, should any protocol deviations occur, the Principal Investigator must report the matter to the Sponsor as soon as reasonably practical. Details of the deviation and, if possible, the reason for its occurrence must be included in the study report. Major modifications will need further approval, and will be submitted to the local authorities or ethics committees, according to local regulations, in the form of an Amendment. Minor administrative changes require only that the Chairman of the Ethics Committee be informed in writing without delay.
Protocol Amendments. (All studies) Prepare and submit proposed substantial amendments of the Protocol to the regulatory authority(ies), relevant ethics committee and NHS Site. Sponsor Ensure all investigators are aware of dates of approval and implementation of all such amendments. Sponsor and NHS Organisation Study Conduct (All studies) Ensure that legislation in relation to research is followed within the Site NHS Organisation Ensure that the Study Site team members are appropriately qualified and experienced to undertake the conduct of the Study and that they have current substantive or honorary employment contracts in place, where required. NHS Organisation Ensure that no Participant is recruited until a favourable ethical opinion has been provided Sponsor and NHS Organisation Ensure that no Participant is recruited to the Study until satisfied that all relevant regulatory permissions and approvals have been obtained. Sponsor and NHS Organisation Put and keep in place arrangements to allow all investigators to conduct the Study in accordance with the Protocol and clause 2 of this Agreement Sponsor and NHS Organisation Ensure that the Study is managed, monitored and reported as agreed in the Protocol. Sponsor and NHS Organisation Ensure that the rights of individual Participants are protected and that they receive appropriate medical care whilst participating in the Study. NHS Organisation Maintain and archive Study documentation at the Site. NHS Organisation Ensure that all data and documentation are available for the purposes of monitoring, inspection or audit and that the appropriate consent has been provided by the Participant. NHS Organisation Inform appropriate health or social care professionals if their patient is a Participant in the Study in accordance with the Research Governance Framework. NHS Organisation Ensure adequate facilities, resources and support is available to conduct the Study at the Site. NHS Organisation Report suspected research misconduct. Sponsor and NHS Organisation Notify the regulatory authority(ies) of the end of the Study. Sponsor Notify the regulatory authority(ies) and relevant ethics committee if the Study is terminated early. Sponsor Adverse events (All studies) Maintain detailed records of all adverse events as specified in the Protocol. Sponsor and NHS Organisation Report adverse events as agreed in the Protocol and to legal requirements and in accordance with NHS Organisation policy. Sponsor and NHS Organisation Promptly inform regul...
Protocol Amendments. No changes from the final approved (signed) protocol will be initiated without the prior written approval or favorable opinion of a written amendment by the IEC/IRB, except when necessary to eliminate immediate safety concerns to the patients or when the change involves only logistics or administration. Each principal investigator and the sponsor will sign the protocol amendment.
Protocol Amendments. Any amendment to the protocol will be written by the Sponsor. Protocol amendments cannot be implemented without prior written IRB approval except as necessary to eliminate immediate safety hazards to subjects. A protocol amendment intended to eliminate an apparent immediate hazard to subjects may be implemented immediately, provided the IRBs are notified within five working days.
Protocol Amendments. 20.1. Subject to Article 20.2, this Protocol may only be amended with the agreement of GGYC, the Challenger of Record and a majority of the Competitor Forum.
Protocol Amendments. 5.1 All amendments to the Protocol approved by Sponsor in writing shall be submitted in writing by Investigator to the Ethics Committee and RA (ŠÚKL). Amendments to the Protocol shall not be implemented until the approval of the Ethics Committee and RA (ŠÚKL) has been granted.
Protocol Amendments. Substantial amendments will be submitted to the IEC for written approval and where applicable to National Competent Authorities. Written approval must be obtained before implementation of the amended version occurs. The written signed approval from the IEC should specifically reference the Principal Investigator’s name, protocol number, study title and amendment number(s) that is/are applicable.
Protocol Amendments. (All studies) Prepare and submit proposed substantial (and, for studies of investigational medical devices, non-substantial) amendments to all relevant ethics committee(s) and, if appropriate, regulatory authority(ies) Ensure the Principal Investigator is informed of all amendments requiring implementation at Site, including the date on which the amendment should be implemented Ensure all amendments of which the site is notified and that require local implementation are implemented at Participating Site Study Conduct (All studies) Ensure that the Study is managed according to GCP, all relevant legislation, and the Protocol Ensure that the Study is locally conducted according to GCP, all relevant legislation, and the Protocol Ensure that the Participating Site team members are appropriately qualified and experienced to undertake the conduct of the Study and that they have current substantive or honorary employment contracts in place, where required Ensure that no Participant is recruited at Site until the Participating Site has been activated by the Sponsor Ensure that the Study is managed, monitored and reported as agreed in the Protocol Maintain Investigator Site File (and Pharmacy Site File, where relevant) at Participating Site, ensuring compliance with Sponsor requirements and applicable guidance/legislation Maintain Trial Master File, ensuring compliance with applicable guidance/ legislation Assess capability of Participants to give informed consent Ensure all Participants receive current version of the patient information sheet, are fully informed about the Study and, having been given sufficient time to consider their participation, have confirmed their willingness to take part by signing the consent form for the Study (including, where applicable, assent). Ensure that the rights of individual Participants are protected and that they receive appropriate medical care whilst participating in the Study. Ensure that all data and documentation are available for the purposes of monitoring, inspection or audit Inform appropriate health or social care professionals if their patient is a Participant in the Study, if required Ensure relevant protocol deviations, and all serious breaches of trial conduct and/or GCP are reported to the Sponsor Report suspected research misconduct, including through notification to the Participating Site Report suspected research misconduct, including through notification to the Sponsor Notify...
Protocol Amendments. Only the Sponsor (or an authorized representative) will make modifications to the clinical study protocol, which will be documented in a written amendment that describes all changes that will be implemented. Protocol amendments will be categorized as either substantial or non- substantial. Protocol amendments will be considered substantial when the changes have significant impact on: - The safety of physical or mental integrity of the subjects - The scientific value of the study - The conduct or management of the study - The quality or safety of any investigational medicinal product or control used in the study Protocol amendments will be considered non-substantial when the changes affect only administrative issues with the conduct of the study, i.e. changes in telephone numbers or addresses. The Sponsor (or an authorized representative) will be responsible for notifying the appropriate national regulatory authorities in writing of any amendments to the protocol prior to the changes being implemented except in those cases where the changes are necessary to eliminate an immediate hazard to the clinical study subjects. Substantial amendments will require written approval by the IEC/IRB prior to being implemented by the Investigator at the study site except under those circumstances described previously. Non-substantial amendments will not require approval by the IEC/IRB unless requested by the IEC/IRB.
Protocol Amendments. The BLM or the SHPO may request amendment of this Protocol at any time, whereupon the parties will consult to consider such amendment. Amendments will become effective upon signature of both parties and will be attached to this protocol.
