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. Pre-screening activities include questions of digital use time and symptomatology and also administering the CVS-Q. Subjects must also have use of a mobile digital device with active data and text plan, able to receive email and text messages. 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.
