Dos and Donts of Monitoring

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Dos and Donts of Monitoring

• Karla McBrady
• Clinical Research Institute
• MN ACRP February 16, 2006

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Purpose

• Discuss the trial tools provided to sites, what
  works, what does not, and why.
• Evaluate case studies of some stumbling blocks
  that arise in the sponsor / site relationship and
  how to effectively address these issues.

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Relationships
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First Impressions Site Initiation

• Be punctual and prepared.
• Send handouts in advance or bring copies.
• Respect the PIs time.
• Be approachable and professional

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Homework

• Know the Protocol and Therapeutic Area
• Ensure proper pronunciation of common terms used
  in therapeutic area
• Address Questions
• If the CRA / Sponsor, is not absolutely sure of
  the answer, it is okay to say you dont know,
  just dont give your best guess
• Be open to feedback
• A lot of protocol errors are discovered by sites
  reviewing the study materials
• A high fat / sugar treat is an effective and
  economical way to build rapport!

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Interim Monitoring Visits

• Do
• respect the office hours.
• inform the coordinator if you are bring extra
  help / trainees.

• Do Not
• expect the coordinator to stay late.
• be nosy about other studies being conducted at
  the site.

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Confidentiality

• Your copy machine is so slow, I am going to just
  run over to Kinkos to make copies of these
  diaries.
• Oh I see you are doing a study for Company X. I
  used to work for them, how are they doing with
  Drug 123?
• Since you have to leave at 430, I am just going
  to take some of these CRFs and charts back to my
  room to finish up.

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Common Sense

• Research subjects are humandiaries will not be
  perfect and there will be visits out of window.
• If you see a suspicious trend, talk to the
  research manager or PI.
• Do not ask for nuisance protocol deviations to
  be sent the IRB.
• It is physically impossible to get an ECG, blood
  draw and vitals at exactly 10 minutes post dose.

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Situation

• A CRA discovers that a subject signed informed
  consent after undergoing study specific testing.
• How should a CRA handles this?
• Question the person who obtained informed consent
  to clarify the circumstances surrounding the
  deviationdo not assume the worst.
• Focus on traininghow did this message not get
  through at study initiation?
• Carefully monitor informed consent compliance at
  subsequent visits.

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What is our job?

• When signing off on lab results, the PI uses NS
  for out of range lab values that are Not
  significant.
• Per the investigator training manual, the proper
  way to indicate that a lab values is not
  significant is to write NCS for Not clinically
  significant.
• What is a CRA to do? Is this affecting the
  safety and wellbeing of our subjects?

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Queries Happen

• Experienced CRAs and CRCs will always get
  queries.
• Take a deep breath and learn from data
  managements approach.
• Teach data management as needed.
• As a CRA, check with the manager if you are not
  100 if a query is needed.
• For one trial, Bradycardia is considered anything
  below 60 bpm, for another trial it is anything
  below 50 bpm.

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Communication!!!

• Who do you call
• for protocol exceptions?
• if your CRA is unavailable?
• for problems with equipment?
• IVRS issues?
• for ordering study drug or equipment?
• for ordering additional lab supplies?

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Trial Tools Advertising

• Database
• Physician referrals
• Posters / Flyers
• Print Ads
• Direct Mail
• National Ads

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FDA Guidelines for Advertisements

• Any advertisement used to recruit subjects should
  be limited to
• The name and address of the clinical Investigator
  and / or research facility
• The condition under study and / or the purpose of
  the research
• In summary form, the criteria that will be used
  to determine eligibility for a study
• A brief list of participation benefits, if any
  (i.e., study medication, no-cost examinations,
  reimbursement for time / travel)
• The time or other commitment required of the
  subjects
• The location of the research and the person or
  office to contact for further information
• The treatment under study is investigational
• No claims can be made!

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Advertising Database Physician Referral

• Databases specifically designed for clinical
  trials can be very effective tools.
• An example database search
• Age 35-65
• Nonsmoker / less than 10 pack years
• Diagnosed with Asthma and Allergies
• Available for extended day visits
• Exclude subjects on beta-blockers

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Advertising Posters / Flyers

• Useful for posting in research center / clinic.

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Advertising National Ads

• At CRI, about 98 of national advertising
  campaigns have not been useful to our site.
• Most marketing firms do not understand the
  research audience
• Example A COPD national ad showed a lovely older
  woman, surrounded by her family, blowing out
  candles on a birthday cake. Fine print at the
  bottom said, Dont let shortness of breath stop
  you from the fun things in life. The picture was
  so big and the print so small it could easily be
  mistaken for an advertisement for Depends!

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National Ads Why not?

• National marketing firms are not familiar with
  the local market for advertising
• Radio ads for COPD were placed on the local
  stations with the highest ratings, which was very
  expensive. WCCO was a good, economical choice,
  KQRS was not!

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National Ads Why Not?

• Trust
• A local name and number generates trust.
• Prescreen services
• The people taking the calls read off of a script,
  keep the subject on the phone a long time and
  cannot think outside of the box. Typically the
  people forwarded to us need to be completely
  re-screened and are usually not eligible.

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Advertising Direct Mail

• Pros
• Generate a large response
• Cons
• Respondents are eligible for a study, but not for
  the sponsor that did the advertisement
• People get angry about how their information was
  found

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Roadblocks

• Case Studies Role Playing