Alzheimer’s Disease Cooperative Study
University of California, San Diego
CLINICAL TRIALS EXPERIENCE FORM
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Alzheimer’s Disease Cooperative Study
University of California, San Diego
CLINICAL TRIALS EXPERIENCE FORM
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Alzheimer’s Disease Cooperative Study
University of California, San Diego
CLINICAL TRIALS EXPERIENCE FORM
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Alzheimer’s Disease Cooperative Study
University of California, San Diego
CLINICAL TRIALS EXPERIENCE FORM
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  1. 1. Alzheimer’s Disease Cooperative Study University of California, San Diego CLINICAL TRIALS EXPERIENCE FORM Page 1 of 4 Return to: Barbara Bartocci bbartocci@ucsd.edu Today’s Date: What study are you applying for? PRE-STUDY CONTACT INFORMATION Name of person completing this form: Institution/Department: Street Address: City: State: Zip Code: Phone: Fax: E-mail: PATIENT POPULATION Number of New AD patients evaluated per year: %Female: %Male: %Minority: Number of New MCI patients evaluated per year: Briefly describe ability to recruit normal healthy controls: List available minority groups: INVESTIGATOR CONTACT INFORMATION Investigator Name: Specialty: Institution/Department: Street Address: City: State: Zip Code: Phone: Fax: E-mail:
  2. 2. Alzheimer’s Disease Cooperative Study University of California, San Diego CLINICAL TRIALS EXPERIENCE FORM Page 2 of 4 Number of AD patients currently followed: %MildAD (MMSE22-26): %MCI: %Severe: Has your site previously conducted any AD trials? Yes No Total number recruited into clinical trials in last 3 years: PERFORMANCE SITE Alzheimer’s Disease Research Center Clinical Research Center Alzheimer’s Disease Center Private Practice Other (Specify): Have you or this site been audited by the FDA or other regulatory agency in the last 5 years? Yes No STAFF RESOURCES Neurologist # Geriatrician # Psychologist # Neuropsychologist # Psychiatrist # Study Coordinator #FT: #PT: Phlebotomist or trained personnel who can draw blood If yes, can this person separate serum and/or plasma from whole blood? Yes No Investigational pharmacy % Effort at this site dedicated to clinical research: EQUIPMENT Indicate which of the following is available at your site. Centrifuge Refrigerator 2-8º C Freezer -30º C non frost-free Dry Ice Freezer -70º C Crash cart EKG Secure storage area 1.5T MRI Scanner Manufacturer: 3T MRI Scanner Manufacturer:
  3. 3. Alzheimer’s Disease Cooperative Study University of California, San Diego CLINICAL TRIALS EXPERIENCE FORM Page 3 of 4 PET Scanner Manufacturer: PROCEDURES Does your site have experience in any of the following? Lumbar Punctures If yes, indicate method(s) of collection: Gravity Syringe If yes, indicate needle type(s): Sprotte Sharp Name: IV Infusion Name: Pharmacokinetic/pharmacodynamic (PK/PD) blood sampling (i.e., collection of blood samples at timed intervals)? Name: Name of person certified in ADAS-Cog administration: Name: No one certified Name of person certified in CDR administration: Name: No one certified Electronic Data Capture/eCRFs Interactive Voice Response System (for randomization) Is there any procedure above that your site would not be willing to participate in? Who is your local IRB? How often does your local IRB meet? meetings per Week Month Year Refrigerator 2-8º C What is the average turn around time on approval? Please specify if there is another committee/institution that must meet in addition to your local IRB CLINICAL TRIALS EXPERIENCE IN LAST FIVE YEARS Drug Classification and Phase Drug Name Sponsor Study Duration (months) Month of Study or indicate “completed” Target Enrollment Number at your site Number of Subjects Enrolled at your site 1 2
  4. 4. Alzheimer’s Disease Cooperative Study University of California, San Diego CLINICAL TRIALS EXPERIENCE FORM Page 4 of 4 3 4 5 6 7 8 9 10 11 12 COMMENTS

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