TTR Questionnaire

Please complete the form below if you are interested in becoming a THAOS investigator. The form will be submitted on your behalf to THAOS@pfizer.com

If you have any questions concerning eligibility, please contact THAOS@pfizer.com directly, or call 001-212-733-9242.

SECTION 1: INVESTIGATOR DETAILS

Investigator First Name: *

Investigator Last Name: *

Title/Salutation: *

Name of Institution: *

Address (Line 1): *

Address (Line 2): *

Town/City: *

Zip/Postal Code: *

State/Province:*

Country:*

Phone number (please include country code, e.g. +1 406 597 3274, +44 162 735 4089):*

 

Fax (please include country code, e.g. +1 406 597 3274, +44 162 735 4089):

 

Email:*

Medical Specialization: *

 
Please select
Cardiologist
Neurologist
Other medical specialization (please specify):

Medical Sub-Specialization (if any):

 

SECTION 2: PATIENT POPULATION

   
Mutation
List Other Mutations
 
   

     Val30Met

     Val122Ile

If you have a subject database, how many subjects do you have in your database by mutation?

        

How many families do you have in your database by mutation?

        

How many TTR subjects do you see per year per mutation (e.g. Val30Met, Val122IIe, Glu89Gln etc.)?

        

How many NEW subjects do you see per year?

        

What percentage of your patients are in the early stage of the disease (Stage I of Coutinho Classification)?

What percentage of your patients have received a liver transplant?

How many patients would you anticipate enrolling in a period of 12 months?


SECTION 3: STANDARD OF CARE FOR TTR PATIENTS

How frequently do your TTR patients see you as part of your standard of care (i.e. every 6 months, every year, no set frequency etc.)?

Do you have a neurologist to complete these assessments:

       Reflexes
       Pin prick
       Light touch
       Vibration
       Position sense
       Motor assessment
 

If no, would you be willing to perform the above assessments?:      Yes No


SECTION 4: SITE CLINICAL TRIAL EXPERIENCE

Do you have experience managing a clinical study:      Yes No

Please indicate the level of clinical study experience in the last 5 years of the Principal Investigator:

      Number of Healthy Volunteer Studies

   

      Number of Patient Studies:

   

      Number of Non-Interventional or Registry Studies:

   

Does your site have any ongoing or scheduled clinical trials for the coming year that:

      Are a TTR double-blinded study?      Yes No
      Would compete with this study for study staff personnel and other resources?      Yes No
      Reduce your expectation to the study?      Yes No

How many staff could you delegate to be involved in this study? From experience we have found that Principal Investigators benefit from the support of a Sub-Investigator and/or Study Coordinators to assist with data entry in the study database and maintenance of study documentation:

      Co-/Sub-Investigators:

   

      Study coordinators:

   

      Cardiologists:

   

      Neurologists:

   

SECTION 5: AGREEMENT

All Principal Investigators and Sub-Investigators conducting this study are required to demonstrate GPP compliance. To achieve compliance with the GPP course training requirement, investigators must either complete the Pfizer GPP for Investigational Site Staff course, or provide proof of completion of a Pfizer-approved GPP equivalent training program.

Please confirm that you agree to this requirement on behalf of yourself as Principal Investigator and all supporting Sub-Investigators on the study.  

Please complete the following security requirements below by rearranging the blue numbers to match the grey sequence:

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THANK YOU FOR TAKING THE TIME TO COMPLETE THIS QUESTIONNAIRE.

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