Additional safeguards that may be included in a social and behavioral study may include:
Requiring pregnancy tests before administration of the study drug
Requiring a legally authorized representative to provide signed consent for an incapacitated subject.
Remove all direct identifiers from the data as soon as possible.
Frequent monitoring of the subject’s heart through ECG after administration of the study drug.
Additional safeguards that may be included in a social and behavioral study may include:…
Additional safeguards that may be included in a social and behavioral study may include: