Failing to obtain informed consent prior to randomization
Subjects were added to IVRS prior to consent and could not be removed from the system when parents would not consent
Enrolling subjects who were not eligible
Randomizing three subjects to the wrong study arm
Administering investigational product that had undergone a 30 minute temperature excursion
Failing to perform study required follow up phone calls
Three subjects received prohibited concomitant study medications
EDC audit trails show that procedures originally entered as not done, and not documented in source records were changed to having been done due to a reason of ‘entry error’.
Consent documentation errors, including:
Signing consents prior to the subject’s parents signed
Failing to retain original documents
Changing the time of the consent to appear that consent occurred prior to dosing
FDA did not post any warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week. From the archives, here is the clinical inspection summary for Bictarvy submitted by Gilead. Five sites were selected for inspection based on treatment effect, financial disclosure and prior inspection history. One site received a FDA Form 483.
Dr. Charest was cited for:
- Failing to provide a participant with an updated consent form. FDA notes that the participant was provided with a consent form for a different study and notes that procedures performed on Week 60 and Week 72 were performed without appropriate consent.
FDA did not post any warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week. From the archives, here is the Clinical Inspection Summary for Anoro Ellipta submitted by GSK. Two sites were inspected based on enrollment, efficacy and dropout rate. Inspections ranged over four to five days. One site received an FDA form 483.
Dr. Sonne was cited for:
- Failing to specify in source records the identity of the person recording the information
- Including post-it notes in source records, specifying the withdrawal of consent of one subject and medication changes for another subject