C164345Level 6

Informed Consent Process Deviation

**Semantic type:** Conceptual Entity

**Definition:** An indication that the informed consent processes or procedures defined the study protocol were not followed.

**Synonyms:** - Informed Consent (IC) process deviation - Informed consent (IC) process

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C209829Consent Form Document Not Signed/Dated By Study Participant or Parent/Legally Authorized Representative

C209830Signed Informed Consent Form that Was Not Protocol Specific

C209831Failure to Document Informed Consent Process

C209832Patient/Study Participant Signed Informed Consent Form Containing Changes not Approved by CIRB/IRB

C209833Translated Consent, Short Form or Other Form of Translation Not Available or Signed/Dated by a Non-English Speaking Patient/Study Participant

C209835Consent Form Signed Was Not Most Current IRB-Approved Version at the Time of Patient Registration

C209836Informed Consent Form Signed After Registration/Enrollment

C209837Informed Consent Form Does Not Contain All Required Signatures

C209838Re-consent Not Obtained as Required

C209844Lab/Imaging/Other Investigation After Withdrawal of Consent

C225568Informed Consent Not Signed/Dated per Local Regulatory Guidelines

C225569Informed Consent Signed/Dated After Study Procedures Initiated

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