Common use of Informed Consent Clause in Contracts

Informed Consent. The Principal Investigator shall obtain the written informed consent of each Subject prior to any screening or participation in the Study using the Informed Consent Materials (as defined in Section 11.3) and in accordance with Applicable Laws. Institution shall cause each Subject to complete an informed consent form that has been reviewed and approved in advance by SPONSOR and by an institutional review board approved by the Institution that complies with the requirements of 21 C.F.R. Part 56 (“IRB”). The Informed Consent Materials shall not be modified or amended without prior written approval of the SPONSOR and IRB.

Appears in 4 contracts

Samples: Efs Master Clinical Study Agreement, Efs Master Clinical Study Agreement, Efs Master Clinical Study Agreement

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Informed Consent. The Principal Investigator shall obtain the written informed consent of each Subject prior to any screening or participation in the Study using the Informed Consent Materials (as defined in Section 11.310.3) and in accordance with Applicable Laws. Institution Each Subject shall cause each Subject to complete an informed consent form that has been reviewed and approved in advance by SPONSOR and by an institutional review board approved by the Institution that complies with the requirements of 21 C.F.R. Part 56 (“IRB”). The Informed Consent Materials shall not be modified or amended without prior written approval of the SPONSOR and IRB.

Appears in 2 contracts

Samples: Clinical Study Agreement, Clinical Study Agreement

Informed Consent. The Principal Investigator shall obtain the written informed consent of each Subject prior to engaging them in any screening Study activities or participation in the Study assessments using the Informed Consent Materials (as defined in Section 11.3) and in accordance with Applicable Laws. Institution shall cause ensure that each Subject to complete completes an informed consent form ICF that has been reviewed and approved in advance by SPONSOR and by an institutional review board approved by the Institution that complies with the requirements of 21 C.F.R. Part 56 (“IRB”). The Informed Consent Materials shall not be modified or amended without prior written approval of the SPONSOR and IRB.

Appears in 2 contracts

Samples: Efs Master Clinical Study Agreement, Efs Master Clinical Study Agreement

Informed Consent. The Principal Investigator shall obtain the written informed consent of each Subject prior to engaging them in any screening Trial activities or participation in the Study assessments using the Informed Consent Materials (as defined in Section 11.3) and in accordance with Applicable Laws. Institution shall cause ensure that each Subject to complete completes an informed consent form ICF that has been reviewed and approved in advance by SPONSOR and by an institutional review board approved by the Institution that complies with the requirements of 21 C.F.R. Part 56 (“IRB”). The Informed Consent Materials shall not be modified or amended without prior written approval of the SPONSOR and IRB.

Appears in 1 contract

Samples: Efs Master Clinical Trial Agreement

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Informed Consent. The Principal Investigator shall obtain the written informed consent of each Subject prior to any screening or participation in the Study using the Informed Consent Materials (as defined in Section 11.310.3) and in accordance with Applicable Laws. Institution Each Subject shall cause each Subject to complete an informed consent form that has been reviewed and approved in advance by SPONSOR AstraZeneca and by an institutional review board approved by the Institution that complies with the requirements of 21 C.F.R. Part 56 (“IRB”). The Informed Consent Materials shall not be modified or amended without prior written approval of the SPONSOR and IRB.

Appears in 1 contract

Samples: Clinical Study Agreement

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