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Physician Clinical Trial Application
SECTION I: INVESTIGATOR INFORMATION
Investigator Name:
First Name
Last Name
Investigator Contact Information:
Street No
Street Name
Postal / Zip Code
Town / City
Province / State (if Applicable)
Country
Work Phone Number
Mobile Phone Number
Email Address
Study Coordinator:
Do you have a dedicated Study Coordinator?
Yes
No
If yes, please provide your Study Coordinator's contact information below.
Study Coordinator Name:
First Name
Last Name
What is their employment type? (select all that apply)
Full time
Part time
Casual
Contract
What is the Study Coordinator's contract end date?
N/A
Study Coordinator Contact Information:
Street No
Street Name
Postal / Zip Code
Town / City
Province / State (if Applicable)
Country
Work Phone Number
Mobile Phone Number
Email Address
SECTION II: CLINICAL SITE QUESTIONS
Name of Affiliated Hospital:
Name of Affiliated University:
Name of Other Site Investigator(s):
What is your specialty area of practice?
Are you board certified or equivalent in your country?
Yes
No
If yes, in what specialty area(s) do you have board certification/equivalent in your country?
Have you received Good Clinical Practice (ICH-GCP) training within the past two years?
Yes
No
Do you have experience conducting regulated trials (e.g., Health Canada, US Food and Drug Administration, European Medicines Agency, etc.)?
Yes
No
How many clinical trials have you previously participated in?
1
2
3
4
5+
Are you currently participating in any industry-sponsored clinical trials?
Yes
No
Has your Research Coordinator received Good Clinical Practice (ICH-GCP) training within the past two years?
Yes
No
Does your Study Coordinator have experience conducting regulated trials (e.g., Health Canada,US Food and Drug Administration, European Medicines Agency, etc.)?
Yes
No
How many clinical trials has your Study Coordinator previously worked on?
1
2
3
4
5+
Does your clinical site have and follow Standard Operating Procedures (SOPs) for the conduct of clinical research? Please note, these will need to be shared with our coordinating site.
Yes
No
How does your clinical site maintain patient medical records?
Maintain original paper patient medical record
Maintain both paper and electronic patient medical record
Maintain the entire patient medical record in a computerized system
Would personnel from the McMaster University Methods Center be permitted to review medical records for remote and in-person monitoring purposes?
Yes
No
Is your clinical site permitted to submit de-identified participant clinical notes to the McMaster University Methods Center for adjudication purposes?
Yes
No
Unknown
Approximately how many metastatic bone disease (MBD) patients with disease in the proximal femur do you treat surgically each year?
<10
10-19
20-29
30-39
40+
Are you comfortable doing ALL of the following surgical procedures in a patient with MBD of the proximal femur: internal fixation of the proximal femur, femoral endoprosthetic reconstruction, hip arthroplasty?
Yes
No
Are all of the surgical procedures mentioned above completed at your site?
Yes
No
If no, please explain:
Is it permitted at your site for the Study Coordinator to be present during surgery?
Yes
No
SECTION III: CLINICAL TRIAL QUESTIONS
Are you comfortable with your patients with MBD of the proximal femur being randomized to either reconstruction or internal fixation (i.e. do you have clinical equipoise)? The inclusion and exclusion criteria are listed below:
Yes
No
Inclusion Criteria
Exclusion Criteria
Life expectancy of at least 6 months
Lesions isolated to the femoral neck
Lesions in the proximal femur (femoral neck, intertrochanteric region, subtrochanteric region, and combinations thereof)
Lesion with any femoral head involvement
Low or intermediate risk for perioperative morbidity and/or mortality
High risk for perioperative morbidity and/or mortality
No more than 75% and no less than 25% bone loss
Multidisciplinary decision that resection of the entire lesion would be indicated
Do you foresee any logistical challenges with ensuring that the surgical equipment will be available at your site for either randomized group?
Yes
No
If yes, please specify:
Do you anticipate any challenges with documenting the following study event data for each study participant: Local recurrence, reoperations, death (if applicable)?
Yes
No
If yes, please specify:
Do you anticipate any challenges with administering questionnaires for study participants to complete, including a log recording days at home, at your clinical site at the 2 week, 6 week, 4 month, 6 month, 9 month, & 12 month post-surgery study visits?
Yes
No
If yes, please specify:
Do you anticipate any clinical site-specific challenges with maintaining 1-year study participant follow-up?
Yes
No
If yes, please specify:
Based on the information provided, are you interested in participating in the PERFORM trial?
Yes
No
Is there anything else we should know that may be relevant to your participation in the PERFORM trial?
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PERFORM Trial Centres
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Become A PERFORM Investigator
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