Informed Consent. 1.6.1 Institution/Principal Investigator undertakes to use the patient information sheet as approved by the Ethics Committee and to obtain written informed consent from each Study subject prior to inclusion or initiation of any Study specific procedures for screening according to the Protocol.
Appears in 10 contracts
Samples: Clinical Trial Agreement, Clinical Trial Agreement, Clinical Trial Agreement
Informed Consent. 1.6.1 2.6.1 Institution/Principal Investigator undertakes to use the patient information sheet as approved by the Ethics Committee and to obtain written informed consent from each Study subject prior to inclusion or initiation of any Study specific procedures for screening according to the Protocol.
Appears in 4 contracts
Samples: Clinical Trial Agreement, Clinical Trial Agreement, Clinical Trial Agreement
Informed Consent. 1.6.1 Institution/Principal Investigator undertakes to use the patient information sheet as provided by Sponsor and approved by the Ethics Committee and to obtain written informed consent from each Study subject prior to inclusion or initiation of any Study specific procedures for screening according to the Protocol.
1.6.2 It is the sole responsibility of Sponsor that information that must be provided to Study subjects as required by article 13 in the GDPR are included in the informed consent forms and that the informed consent form meets the requirements in the GDPR.
Appears in 2 contracts
Informed Consent. 1.6.1 Institution/Principal 1.5.1 Investigator undertakes to use the provide patient information sheet sheet(s) as approved by the national Ethics Committee in any language requested, and to obtain written informed consent according to national guidelines and regulations from each Study subject prior to inclusion or initiation of any Study specific procedures for screening according to the Protocol.
Appears in 2 contracts
Informed Consent. 1.6.1 Institution/Principal Site Investigator undertakes to use the patient information sheet as approved by the Ethics Committee and to obtain written informed consent from each Study subject prior to inclusion or initiation of any Study specific procedures for screening according to the Protocol.
Appears in 1 contract
Samples: Clinical Trial Agreement
Informed Consent. 1.6.1 Institution/Principal Investigator undertakes to use the provide patient information sheet sheet(s) as approved by the national Ethics Committee in any language requested, and to obtain written informed consent according to national guidelines and regulations from each Study subject prior to inclusion or initiation of any Study specific procedures for screening according to the Protocol.
Appears in 1 contract
Samples: Clinical Trial Agreement