Which of the following would the sponsor need to do FIRST to set up an effective clinical trial quality management system (QMS)?

• A. Perform a periodic review to see if the quality methods are effective and relevant.
• B. Train the research coordinator on the required study assessments schedule.
• C. Identify critical processes and data during protocol development.
• D. Determine the quality tolerance limits for data transcription errors.

Who determines what criteria and procedures should be followed if a subject discontinues/withdraws their consent?

• A. Subject
• B. Sponsor
• C. CRO
• D. PI

A quality assurance audit of the EDC system SOP revealed a deficiency. Which of the following is the MOST likely reason?

• A. The number of unique eCRF templates was not specified.
• B. The list of comparable technology solutions was not included.
• C. The number of users with access was not defined.
• D. The frequency of data backup was not defined.

While consenting a potential subject, a coordinator discovered the subject could not read. Under what conditions can this potential subject be enrolled?

• A. Locate a translator and have them work with the person.
• B. Have the Principal Investigator consent the person.
• C. Get an impartial witness involved in consenting this person.
• D. There are no circumstances under which this person can be enrolled.

Confidentiality and privacy rules for protection of human subjects at research sites are determined by the:

• A. Sponsor
• B. Applicable regulatory authorities
• C. Applicable site SOPs
• D. PI