Instrument Descriptions:
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Documentation of Informed Consent - This form is used by study personnel to document attestation (if needed) and the informed consent process to comply with IRB policy for any potential future IRB audit.
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a. Upload Consent PDF as Inline image/PDF OR add free text with image of IRB stamp b. ** Include any discrete fields needed for you consent documentation needs, such as storing images, genetic results, etc:c. Ensure e-Consent Framework in the survey settings for each consent instrument is configured correctly as per guidelines found in e-Consent Initial Set-Up.d. If using Manual Consent Upload instrument and multiple forms may need to be uploaded, copy the "Upload copy of signed consent" field as needed to allow for more than 1 upload.e. In-Person Only Consent:If you are consenting in-person only for a non-FDA regulated study, you may add multiple signatures to the instrument and e-consent framework as needed. This does not negate the need for the documentation of informed consent (attestation instrument) if the coordinator signs the consent instrument. f. Separate Assent Forms:If you are using seperate Assent forms for ages 7-12 and 13-17, please copy the Econsent Assent instrument and label it appropriately. You may want to edit the variable names to match your Assent types. |
Resources:
3. Complete survey distribution set up for each electronic consent instrument to be delivered remotely
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