Investigator Application Form

    Investigator Name:

    Investigator Address:

    Do you have a dedicated Study Coordinator?
    YesNo

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

    Study Coordinator Name:

    Study Coordinator Work Address:

    SECTION II: CLINICAL SITE QUESTIONS


    Are you board certified?
    YesNo

    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

    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

    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

    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

    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

    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

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

    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

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