Company

Advertisement Review Checklist

Protocol #: Date of Review:

Investigator: Reviewer:

Advertisement Title or Identification:

1. Is the mode of communication appropriate?

2. Does the advertising material, which will be used to recruit potential
subjects, afford adequate protection?
3. Does the advertising material explicitly state that this is a “research study”
or “clinical research trial”?
4. Is the material misleading or coercive?
5. Does the advertisement contain any of the following unacceptable
elements?
 Claims, either explicitly or implicitly, that the drug or device is safe or
effective for the purposes under investigation
 Claims that the drug or device is in any way equivalent or superior to any
other drug or device
 Implied or express claim of safety or effectiveness of study medication
 References to free medical treatment (“research-related” medical
treatment is allowed)
 Undue emphasis on subject compensation (such as “free” or the $ amount
bolded or underlined)
 Any claim that the research will (as opposed to “may”) improve the
subject’s medical condition
 Any express or implied statement that the research is FDA approved
 The words “medicine” or “medication” unless modified with terms such
as “research,” “investigational,” “experimental,” “study,” etc. It should be
clear that the drug is not an approved drug.
 The actual drug name, unless the sponsor approves its use
 Information that is incorrect according to protocol
 If this is a Screening script, does it ask questions related to alcohol or drug
use (i.e., asked before consent is signed)?

Recommendations of Reviewer:
___ Advertisement acceptable and does not require follow-up action (Approved)
___ Advertisement acceptable but suggested corrections need to be incorporated (Conditional)
___ Advertisement not acceptable and requires revision (Disapproved)

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