Instrument Descriptions:
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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 separate 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. |
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3. Complete survey distribution set up for each electronic consent instrument to be delivered remotely
If participant age is to be used to determine which consent form should be sent (i.e., under age 18 send parental permission form), the participant date of birth (dob) and age (age_at_contact) fields in the Participant Contact Info instrument can be used for survey distribution logic.
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Resources:
4. If doing in-person consent ONLY:
The attestation statement field can be removed from the Documentation of Informed Consent instrument.
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