Physician Clinical Trial Application

Investigator Name:

First Name*

Last Name*

Investigator Address:

Street No.

Street Name

Postal / Zip Code

Town / City

Province / State (if Applicable)

Country

Work Phone Number

Mobile Phone Number

Email Address

Do you have a dedicated Study Coordinator?
YesNo

If yes, please provide your Study Coordinator's contact information below.

Study Coordinator Name:

First Name

Last Name

Study Coordinator Work Address:

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?
YesNo

If yes, in what specialty area(s) do you have board certification?

Have you received Good Clinical Practice (ICH-GCP) training within the past two years?
YesNo

Do you have experience conducting regulated trials (e.g., Health Canada, US Food and Drug Administration, European Medicines Agency, etc.)?
YesNo

How many clinical trials have you previously participated in?
12345+

Are you currently participating in any industry-sponsored clinical trials?
YesNo

Has your Research Coordinator received Good Clinical Practice (ICH-GCP) training within the past two years?
YesNo

Does your Study Coordinator have experience conducting regulated trials (e.g., Health Canada,US Food and Drug Administration, European Medicines Agency, etc.)?
YesNo

How many clinical trials has your Study Coordinator previously worked on?
12345+

Does your clinical site have and follow Standard Operating Procedures (SOPs) for the conduct of clinical research?
YesNo

If yes, please submit a copy of the Table of Contents as PDF file (5MB max)

How does your clinical site maintain patient medical records?
Maintain original paper patient medical recordMaintain both paper and electronic patient medical recordMaintain 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?
YesNo

Is your clinical site permitted to submit de-identified participant clinical notes to the McMaster University Methods Center for adjudication purposes?
YesNo

Approximately how many new primary extremity soft-tissue sarcomas do you treat each year?
<1010-1920-2930-3940+

What is your standard practice for post-operative surveillance for lung metastases in soft-tissue sarcoma patients?
Chest CT scanCXROther

If other, please specify:

Are both imaging modalities (CT scan and CXR) available at your clinical site?
YesNo

In the first two post-operative years, how often do you typically see soft-tissue sarcoma patients for follow-up?
Every 3 MonthsEvery 6 MonthsOther

If other, please specify:

SECTION III: CLINICAL TRIAL QUESTIONS

Are you comfortable with your soft-tissue sarcoma patients being randomized to a surveillance regimen that may be more or less intensive than your standard practice?
YesNo

SAFETY trial participants will be randomized to one of four treatment arms:
1) Clinical assessment + CXR every 3 months for 2 years;
2) Clinical assessment + chest CT scan every 3 months for 2 years;
3) Clinical assessment + CXR every 6 months for 2 years; or
4) Clinical assessment + chest CT scan every 6 months for 2 years

Do you foresee any logistical challenges with ensuring that study participants at your clinical site obtain the prescribed thoracic imaging and are assessed in clinic at the appropriate frequency?
YesNo

If yes, please specify:

Do you anticipate any challenges with documenting the following study event data for each study participant (if applicable)?
▪ Oncologic events (such as local recurrence or systemic relapse); and
▪ Treatment-related complications (including chemotherapy-related complications [such as febrile neutropenia, fungal infections or sepsis] and thoracotomy-related complications [such as pneumothorax or surgical site infections])
YesNo

If yes, please specify:

Do you anticipate any challenges with administering the following questionnaires to study participants at your clinical site at the 6M, 12M, 18M, 24M, 36M, 48M and 60M study visits?
▪ PROMIS Cancer-Anxiety Questionnaire;
▪ PROMIS Satisfaction with Social Roles and Activities Questionnaire; and
▪ EQ-5D Questionnaire
YesNo

If yes, please specify:

Do you anticipate any clinical site-specific challenges with maintaining 5-year study participant follow-up?
YesNo

If yes, please specify:

Do you anticipate any challenges with documenting the following clinical site-specific data?
▪ Follow-up care costs (such as costs associated with orthopaedic oncology clinic visits, thoracic imaging [both CT and CXR], imaging interpretation and hospital parking);
▪ Costs associated with unplanned re-operations (such as costs associated with OR time, anesthesia time and type, surgeon time, scrub nurse time, surgical supplies, pain medication and hospital
admission);
▪ Costs associated with oncologic events (such as costs associated with medical oncology visits, radiation oncology visits, chemotherapy and radiation); and
▪ Costs associated with treatment-related complications (such as costs associated with hospital admission, medications and surgery)
YesNo

If yes, please specify:

Based on the information provided, are you interested in participating in the SAFETY trial?
YesNo

Is there anything else we should know that may be relevant to your participation in the SAFETY trial?