Common use of Informed Consent and Screening Clause in Contracts

Informed Consent and Screening. The investigator or delegate must explain the purpose and nature of the study, and have the subject read, sign, and date the IRB/IEC-approved informed consent document. The subject must sign the ICF BEFORE any study-specific procedures or assessments can be performed, including study-specific screening procedures. Additionally, have the individual obtaining consent from the subject and a witness, if applicable, sign and date the informed consent document. The investigator or delegate must provide a copy of the signed document to the subject and place the original signed document in the subject’s chart, or provide documentation as required by local regulations.

Informed Consent and Screening. The investigator or delegate must explain the purpose and nature of the study, and have the subject read, sign, and date the IRB/IEC-approved informed consent document. The subject must sign the ICF BEFORE any study-specific procedures or assessments can be performed, including study-specific screening procedures. Additionally, have the individual obtaining consent from the subject and a witness, if applicable, sign and date the informed consent document. The investigator or delegate must provide a copy of the signed document to the subject and place the original signed document in the subject’s chart, or provide documentation as required by local regulations.. Prescreening for eligibility of potential subjects must be done the using the IRB-approved telephone prescreening script

Informed Consent and Screening. The investigator Investigator or delegate must explain the purpose and nature of the study, and have the subject read, sign, and date the IRB/IEC-approved informed consent document. The subject must sign the ICF BEFORE any study-specific procedures or assessments can be performed, including study-specific screening procedures. Additionally, have the individual obtaining consent from the subject and a witness, if applicable, sign and date the informed consent document. A signed informed consent document defines the point of enrollment. The investigator Investigator or delegate must provide a copy of the signed document to the subject and place the original signed document in the subject’s chart, or provide documentation as required by local regulations.

Informed Consent and Screening. The investigator or delegate must explain the purpose and nature of the study, and have the subject read, sign, and date the IRB/IEC-approved informed consent document. The subject must sign the ICF BEFORE any study-specific procedures or assessments can be performed, including study-specific screening procedures. Additionally, have the individual obtaining consent from the subject and a witness, if applicable, sign and date the informed consent document. The investigator or delegate must provide a copy of the signed document to the subject and place the original signed document in the subject’s chart, or provide documentation as required by local regulations. Optional prescreening for eligibility of potential subjects must be done using the using the IRB-approved script and symptomatology questionnaire.