CLINICAL TRIAL SUBJECT RECRUITMENT AND ENROLLMENT. The Principal Investigator shall make sure that the Clinical Trial Subjects (and/or their legal representatives) will, in accordance with applicable Law, be duly informed and that each give his informed consent prior to his participation in the Clinical Trial. Institution will provide Sponsor/CRO an opportunity to review and approve the content of any Clinical Trial recruitment materials (including the ICF) directed to potential Clinical Trial Subjects before such materials are used, regardless of medium. The Principal Investigator shall use reasonable endeavours to recruit the Target within the Timelines as specified in Annex 2. As soon as the Principal Investigator expects to reach the Target, he shall notify the Sponsor and/or CRO. If circumstances or events have occurred or will occur that will substantially delay or are likely to substantially delay the progress of recruitment or enrolment of the Clinical Trial Subjects, the Principal Investigator shall immediately inform the Sponsor and/or CRO in writing. In each such event the Parties shall discuss the consequences of the delay and each Party shall undertake reasonable endeavours to agree on measures to overcome the delay. In the event that the Clinical Trial is part of a multi-centre clinical trial, the Sponsor may amend the number of Clinical Trial Subjects to be recruited pursuant to the Target as per clause 5.2 above subject to this clause 5.4. The Sponsor may require further recruitment of Clinical Trial Subjects at the Trial Site to cease if: in the reasonable opinion of the Sponsor recruitment of Clinical Trial Subjects at the Trial Site will not meet or will not likely meet the Target within the Timelines or is proceeding at a rate below that required to enable the relevant Timeline to be met, and upon Sponsor’s request to increase the inclusion rate, the Principal Investigator is unable to comply, or if the global recruitment target for all clinical centres of Sponsor and its affiliates has been reached. Upon receipt of a notice subject to clause 5.4 (a), the Principal Investigator shall immediately stop the recruitment and inclusion of Clinical Trial Subjects. The terms and conditions of this Agreement regarding the Clinical Trial Subjects shall also apply to individuals who, at the time of receipt of such notice, have signed the ICF. Payments shall only be made according to the number of Clinical Trial Subjects recruited and included up to the date of receipt of the notice. The Sponsor wi...
CLINICAL TRIAL SUBJECT RECRUITMENT AND ENROLLMENT. 5.1. The Principal Investigator shall make sure that the Clinical Trial Subjects (and/or their legal representatives) will, in accordance with applicable Law, be duly informed and that each give his informed consent prior to his participation in the Clinical Trial.
CLINICAL TRIAL SUBJECT RECRUITMENT AND ENROLLMENT. 5.1. The Principal Investigator shall make sure that the Clinical Trial Subjects (and/or their legal representatives) will, in accordance with applicable Law, be duly informed and that each give his informed consent prior to his participation in the Clinical Trial. Institution will provide Sponsor/CRO an opportunity to review and approve the content of any Clinical Trial recruitment materials (including the ICF) directed to potential Clinical Trial Subjects before such materials are used, regardless of medium.
CLINICAL TRIAL SUBJECT RECRUITMENT AND ENROLLMENT. 5.1. Institution shall make sure or cause the Principal Investigator to make sure that in accordance with applicable legislation and the ICH GCP, the Clinical Trial Subjects and, if required by law, their legal representatives, prior to the Clinical Trial Subjects’ participation in the Clinical Trial (a) will be duly informed, in a language the Clinical Trial Subjects and their legal representatives can fully understand, on all aspects of the Clinical Trial which are required or deemed relevant in their decision to participate, and (b) each give their informed consent.
CLINICAL TRIAL SUBJECT RECRUITMENT AND ENROLLMENT. 5.1. The Sponsor shall make sure that the Clinical Trial Subjects (and/or their legal representatives) will, in accordance with applicable Law, be duly informed and that each give his informed consent prior to his participation in the Clinical Trial.
