Parent(s) ICD Version Correct ICD PI/Designee Is Assent Subject ID Signature & Is ICD Complete? 4 NOTES Date 1 Version? 3 Signature & Date Documented? Date2 Sig: Y N☐ Y N Sig: Y N☐ Y N Y N N/A ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ Date: Date: Sig: Y N☐ Y N Sig: Y N☐ Y N Y N N/A ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ Date: Date: Sig: Y N☐ Y N Sig: Y N☐ Y N Y N N/A ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ Date: Date: Sig: Y N☐ Y N Sig: Y N☐ Y N Y N N/A ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ Date: Date: Sig: Y N☐ Y N Sig: Y N☐ Y N Y N N/A ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ Date: Date: Sig: Y N☐ Y N Sig: Y N☐ Y N Y N N/A ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ Date: Date: Sig: Y N☐ Y N Sig: Y N☐ Y N Y N N/A ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ Date: Date: Sig: Y N☐ Y N Sig: Y N☐ Y N Y N N/A ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ Date: Date: Sig: Y N☐ Y N Sig: Y N☐ Y N Y N N/A ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ Date: Date: Sig: Y N☐ Y N Sig: Y N☐ Y N Y N N/A ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ Date: Date: _____________________________ 1 Ensure the ICD version is correct based on the informed consent version history 2 Make sure signature is signed and dated in parent’s own handwriting. Additional guidance on obtaining parental signatures: 3 Is subject signature date within the ICD version date 4 E.g. all opt in/out boxes are completed OBSERVATIONS AND FOLLOW-UP (describe any concerns noted above)
Subject ID ICD Version Date 1 Parent(s) Signature & Date2 Correct ICD Version? 3 PI/Designee Signature & Date Is ICD Complete? 4 Is Assent Documented? NOTES Sig: Y ☐ N☐ Date: Y ☐ N ☐ Sig: Y ☐ N☐ Date: Y ☐ N ☐ Y ☐ N ☐ N/A ☐ Sig: Y ☐ N☐ Date: Y ☐ N ☐ Sig: Y ☐ N☐ Date: Y ☐ N ☐ Y ☐ N ☐ N/A ☐ Sig: Y ☐ N☐ Date: Y ☐ N ☐ Sig: Y ☐ N☐ Date: Y ☐ N ☐ Y ☐ N ☐ N/A ☐ Sig: Y ☐ N☐ Date: Y ☐ N ☐ Sig: Y ☐ N☐ Date: Y ☐ N ☐ Y ☐ N ☐ N/A ☐ Sig: Y ☐ N☐ Date: Y ☐ N ☐ Sig: Y ☐ N☐ Date: Y ☐ N ☐ Y ☐ N ☐ N/A ☐ Sig: Y ☐ N☐ Date: Y ☐ N ☐ Sig: Y ☐ N☐ Date: Y ☐ N ☐ Y ☐ N ☐ N/A ☐ Sig: Y ☐ N☐ Date: Y ☐ N ☐ Sig: Y ☐ N☐ Date: Y ☐ N ☐ Y ☐ N ☐ N/A ☐ Sig: Y ☐ N☐ Date: Y ☐ N ☐ Sig: Y ☐ N☐ Date: Y ☐ N ☐ Y ☐ N ☐ N/A ☐ Sig: Y ☐ N☐ Date: Y ☐ N ☐ Sig: Y ☐ N☐ Date: Y ☐ N ☐ Y ☐ N ☐ N/A ☐ Sig: Y ☐ N☐ Date: Y ☐ N ☐ Sig: Y ☐ N☐ Date: Y ☐ N ☐ Y ☐ N ☐ N/A ☐ _____________________________ 1 Ensure the ICD version is correct based on the informed consent version history 2 Make sure signature is signed and dated in parent’s own handwriting. Additional guidance on obtaining parental signatures: 3 Is subject signature date within the ICD version date 4 E.g. all opt in/out boxes are completed OBSERVATIONS AND FOLLOW-UP (describe any concerns noted above)
informed_consent_documentation_word_version_0.docx