xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05965401</url>
    </required_header>
    <id_info>
      <org_study_id>REB23-0532</org_study_id>
      <nct_id>NCT05965401</nct_id>
    </id_info>
    <brief_title>Pharmacogenetic-Guided Antidepressant Prescribing in Adolescents</brief_title>
    <acronym>PGx-GAP</acronym>
    <official_title>Pharmacogenetic-Guided Antidepressant Prescribing (PGx-GAP) in Adolescents</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Calgary</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Alberta</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Calgary</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a parallel arm randomized (1:1) controlled trial. Adolescents aged 12-17 years&#xD;
        (n=452) that did not respond or tolerate first-line fluoxetine therapy will be randomly&#xD;
        allocated to receive 12-weeks of pharmacogenetic-guided antidepressant therapy (experimental&#xD;
        intervention) or GLAD-PC guided prescribing (control intervention).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Goal: To test the efficacy of pharmacogenetic-guided antidepressant prescribing for&#xD;
        adolescents with depression.&#xD;
  &#xD;
        Background: For an adolescent with moderate to severe depression, antidepressant medication&#xD;
        is prescribed, often in combination with psychotherapy. The class of antidepressants&#xD;
        recommended for use is selective serotonin reuptake inhibitors (SSRIs) with fluoxetine&#xD;
        recommended as the first-line medication, and four other SSRIs recommended for consideration&#xD;
        (sertraline, citalopram, escitalopram, fluvoxamine) if the adolescent does not respond or&#xD;
        tolerate fluoxetine. For most adolescents, medication prescribing, and monitoring will be&#xD;
        managed by a primary care physician or community pediatrician rather than by a mental health&#xD;
        care provider, and guidelines exist to support this management (Guidelines for Adolescent&#xD;
        Depression in Primary Care, GLAD-PC). However, GLAD-PC does not account for SSRI metabolism&#xD;
        phenotypes that could change whether the SSRI selected is efficacious or tolerated. Our team&#xD;
        of researchers, clinician scientists, patient partners, and primary care providers has&#xD;
        designed a trial to test the impact of accounting for metabolism phenotypes, through&#xD;
        pharmacogenetic-guided antidepressant prescribing, on adolescent outcomes, experiences, and&#xD;
        health care utilization.&#xD;
  &#xD;
        Principal Question: Compared to GLAD-PC informed prescribing, does pharmacogenetic-guided&#xD;
        prescribing for depressed adolescents who have not responded or tolerated first-line&#xD;
        fluoxetine therapy, have superior efficacy following 12-weeks of therapy with an alternative&#xD;
        SSRI?&#xD;
  &#xD;
        The Trial: This is a parallel arm randomized controlled trial. Adolescents aged 12-17 years&#xD;
        (n=452) that did not respond or tolerate first-line fluoxetine therapy will be randomly&#xD;
        allocated to receive pharmacogenetic-guided antidepressant therapy (experimental&#xD;
        intervention) or GLAD-PC guided prescribing (control intervention). Participants and&#xD;
        prescribing physicians will be blinded to which intervention was received. The primary&#xD;
        outcome is depressive symptom remission at 12 weeks measured using the Quick Inventory of&#xD;
        Depressive Symptomatology - Adolescent (17-item) (QIDS-A17). Secondary outcomes include side&#xD;
        effects, role functioning, medication adherence, and health-related quality of life measured&#xD;
        4-, 8-, and 12-weeks after intervention initiation as well as cost-effectiveness.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2027</completion_date>
    <primary_completion_date type="Anticipated">September 2027</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>This is a parallel arm randomized controlled trial.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>Participants, their prescribing physician, and the investigator will all be blinded to study arm. The study coordinator will be the only one unblinded to study arm allocation.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Number of participants with depression remission</measure>
      <time_frame>Baseline to 12 weeks</time_frame>
      <description>Quick Inventory of Depressive Symptomatology - Adolescent - 17-item (QIDS-A17) total score &lt; 6. Scores range from 0-27, with higher scores indicative of more severe depression.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of participants with side effects and adverse drug reactions</measure>
      <time_frame>Baseline to 12 weeks</time_frame>
      <description>Frequency, Intensity, Burden of Side Effects Rating (FIBSER) scale. Total scores range from 0-6 (3 items); cut-points are used to indicate moderate (score of 3) or severe (score of 5) adverse drug reaction/side effect interference with activities.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percent Change in Role functioning</measure>
      <time_frame>Baseline to 12 weeks</time_frame>
      <description>WHO Disability Assessment Schedule. Scores range from 0 to 48, with higher scores indicative of worse role functioning.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percent Change in Depressive Symptom Severity</measure>
      <time_frame>Baseline to 12 weeks</time_frame>
      <description>Quick Inventory of Depressive Symptomatology - Adolescent - 17-item (QIDS-A17). Scores range from 0-27, with higher scores indicative of more severe depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percent Change in clinician assessment of depressive symptom severity</measure>
      <time_frame>Baseline to 12 weeks</time_frame>
      <description>Change in Clinical Global Impression Severity (CGI-S) scale. Scores range from 0-7, with higher scores indicative of more severe illness.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in self-report health care resource use</measure>
      <time_frame>Baseline to 12 weeks</time_frame>
      <description>Resource use questionnaire that captures number of visits and out-of-pocket costs for various mental health services.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in health care utilization</measure>
      <time_frame>Baseline to 12 weeks</time_frame>
      <description>Administrative data will be obtained on medication information (agent, dose, duration) and health care utilization (doctor visits, hospitalizations, emergency room visits).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in health-related quality of life</measure>
      <time_frame>Baseline to 12 weeks</time_frame>
      <description>EuroQoL 5 Dimension - Youth (EQ-5D-Y). Five descriptive items code level of perceived problems in health states and a visual analog scale has a score from 0-100, with higher scores indicative of better health.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in medication adherence</measure>
      <time_frame>4 to 12 weeks</time_frame>
      <description>Medication Adherence Report Scale (MARS-5) scores. Scores range from 5-25 with higher scores indicative of better medication adherence.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in behavioral activation</measure>
      <time_frame>Baseline to 12 weeks</time_frame>
      <description>Emergence of activation based on Treatment-Emergent Activation and Suicidality Assessment Profile. Total scores range from 0-114 (38 items) with higher scores indicating greater behavioral activation.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Minimally clinically important differences</measure>
      <time_frame>12 weeks</time_frame>
      <description>Participant-reported, Global Rating of Change Scale (GRCS) (11-point Likert scale ranging from +5 to -5) to indicate the degree to which symptoms and role functioning changed for the better, for the worse, or no change was experienced.</description>
    </other_outcome>
    <other_outcome>
      <measure>Intervention fidelity</measure>
      <time_frame>12 weeks</time_frame>
      <description>Physician-reported, two-item questionnaire on use of recommendations in the dosing report.</description>
    </other_outcome>
    <other_outcome>
      <measure>Blinding fidelity</measure>
      <time_frame>12 weeks</time_frame>
      <description>Physician-reported, 1-item survey about the perceived allocation of each of their participating patients; response options are 'PGx-guided prescribing', 'don't know' or 'GLAD-PC prescribing'</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">452</enrollment>
    <condition>Depression in Adolescence</condition>
    <arm_group>
      <arm_group_label>Pharmacogenetic (PGx)-Guided</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants and their physician will receive a one-time prescribing report after completing baseline for second-line selective serotonin reuptake inhibitors with dosing information based on CYP2B6, CYP2C19, and CYP2D6 genotype data.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Guidelines for Adolescent Depression in Primary Care (GLAD-PC)-Guided</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants and their physician will receive a one-time prescribing report after completing baseline for second-line selective serotonin reuptake inhibitors based on GLAD-PC dosing guidelines.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Pharmacogenetic-guided dosing</intervention_name>
      <description>SSRI dosing based on Clinical Pharmacogenetics Implementation Consortium's SSRI dosing guidelines.</description>
      <arm_group_label>Pharmacogenetic (PGx)-Guided</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>GLAD-PC guided dosing</intervention_name>
      <description>SSRI dosing based on GLAD-PC clinical practice guidelines</description>
      <arm_group_label>Guidelines for Adolescent Depression in Primary Care (GLAD-PC)-Guided</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 12-17&#xD;
  &#xD;
            -  Depression as the primary concern, confirmed by the treating physician&#xD;
  &#xD;
            -  QIDS-A17 score greater than or equal to 11 indicating moderate-to-severe symptoms&#xD;
  &#xD;
            -  Prior failure of fluoxetine therapy due to inefficacy or intolerance&#xD;
  &#xD;
            -  Intention to start a new SSRI&#xD;
  &#xD;
            -  English fluency&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Co-occurring psychosis, bipolar disorder, eating disorder, autism spectrum disorder,&#xD;
               fetal alcohol spectrum disorder, or intellectual disability&#xD;
  &#xD;
            -  A score of 2 or 3 on suicide item 13 of the QIDS-A17&#xD;
  &#xD;
            -  High-risk alcohol or substance use (excluding cannabis and tobacco) as indicated by a&#xD;
               score of monthly or more on the S2BI&#xD;
  &#xD;
            -  History of non-response to 3 or more antidepressants (including fluoxetine, i.e.&#xD;
               failure of fluoxetine and two other agents) as confirmed by the treating physician&#xD;
  &#xD;
            -  Psychotherapy or brain stimulation-based therapy initiated within 8 weeks of referral,&#xD;
               or plans to initiate/change these therapies during study participation&#xD;
  &#xD;
            -  History of liver or hematopoietic cell transplant&#xD;
  &#xD;
            -  History of CYP2B6, CYP2C19, or CYP2D6 testing&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Chad Bousman, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Calgary</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Amanda Newton, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Alberta</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Laina McAusland, MSc</last_name>
      <phone>403-210-6353</phone>
      <email>gap@ucalgary.ca</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Calgary</name>
        <address>
          <city>Calgary</city>
          <state>Alberta</state>
          <zip>T2N 4N1</zip>
          <country>Canada</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 14, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Calgary</investigator_affiliation>
      <investigator_full_name>Chad Bousman</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>Depression</keyword>
    <keyword>Adolescence</keyword>
    <keyword>SSRI</keyword>
    <keyword>Antidepressant</keyword>
    <keyword>Pharmacogenetics</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depression</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Anonymized, individual participant PGx-GAP data will be shared using a controlled-access model. Under this model, the data will be released to a researcher if access criteria are met.&#xD;
  All requests for data sharing should be made to the Co-Principal Investigators who will be responsible for reviewing and granting requests. Requestors should provide a research proposal for review. In the event that a data sharing request is declined, reasons will be provided to the requestor. If the data sharing request is granted, a data-sharing agreement will be initiated by the Co-Principal Investigators alongside the University of Calgary (lead institution). This agreement will include information on the individual data to be shared; if other documents will be available (e.g., statistical codes, data dictionary), when the data will be available and for how long, and how data access will be provided (e.g., file transfer).</ipd_description>
      <ipd_access_criteria>The requestor is affiliated with an academic institution as an independent investigator or trainee of an independent investigator;&#xD;
  The proposed research question(s) and hypothesis(es) are specific, measurable, and achievable;&#xD;
  The proposed research project will be governed/overseen by a local legal/regulatory body;&#xD;
  The proposed research project poses no risk of invasion of privacy or breaches of confidentiality for trial participants;&#xD;
  A member of the proposed research team has sufficient statistical skills to carry out the proposed analytic plan;&#xD;
  The requestor has sufficient financial and/or human resources to see the proposed research project to completion;&#xD;
  The proposed research question(s) and hypothesis(es) do not conflict with active or planned studies of the Co-Principal Investigators.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05965401
  org study id: REB23-0532
  nct id: NCT05965401
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This is a parallel arm randomized (1:1) controlled trial. Adolescents aged 12-17 years
        (n=452) that did not respond or tolerate first-line fluoxetine therapy will be randomly
        allocated to receive 12-weeks of pharmacogenetic-guided antidepressant therapy (experimental
        intervention) or GLAD-PC guided prescribing (control intervention).
  Goal: To test the efficacy of pharmacogenetic-guided antidepressant prescribing for
        adolescents with depression.
  
        Background: For an adolescent with moderate to severe depression, antidepressant medication
        is prescribed, often in combination with psychotherapy. The class of antidepressants
        recommended for use is selective serotonin reuptake inhibitors (SSRIs) with fluoxetine
        recommended as the first-line medication, and four other SSRIs recommended for consideration
        (sertraline, citalopram, escitalopram, fluvoxamine) if the adolescent does not respond or
        tolerate fluoxetine. For most adolescents, medication prescribing, and monitoring will be
        managed by a primary care physician or community pediatrician rather than by a mental health
        care provider, and guidelines exist to support this management (Guidelines for Adolescent
        Depression in Primary Care, GLAD-PC). However, GLAD-PC does not account for SSRI metabolism
        phenotypes that could change whether the SSRI selected is efficacious or tolerated. Our team
        of researchers, clinician scientists, patient partners, and primary care providers has
        designed a trial to test the impact of accounting for metabolism phenotypes, through
        pharmacogenetic-guided antidepressant prescribing, on adolescent outcomes, experiences, and
        health care utilization.
  
        Principal Question: Compared to GLAD-PC informed prescribing, does pharmacogenetic-guided
        prescribing for depressed adolescents who have not responded or tolerated first-line
        fluoxetine therapy, have superior efficacy following 12-weeks of therapy with an alternative
        SSRI?
  
        The Trial: This is a parallel arm randomized controlled trial. Adolescents aged 12-17 years
        (n=452) that did not respond or tolerate first-line fluoxetine therapy will be randomly
        allocated to receive pharmacogenetic-guided antidepressant therapy (experimental
        intervention) or GLAD-PC guided prescribing (control intervention). Participants and
        prescribing physicians will be blinded to which intervention was received. The primary
        outcome is depressive symptom remission at 12 weeks measured using the Quick Inventory of
        Depressive Symptomatology - Adolescent (17-item) (QIDS-A17). Secondary outcomes include side
        effects, role functioning, medication adherence, and health-related quality of life measured
        4-, 8-, and 12-weeks after intervention initiation as well as cost-effectiveness.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This is a parallel arm randomized controlled trial.
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: Participants, their prescribing physician, and the investigator will all be blinded to study arm. The study coordinator will be the only one unblinded to study arm allocation.
  measure: Number of participants with depression remission
  time frame: Baseline to 12 weeks
  description: Quick Inventory of Depressive Symptomatology - Adolescent - 17-item (QIDS-A17) total score < 6. Scores range from 0-27, with higher scores indicative of more severe depression.
  measure: Number of participants with side effects and adverse drug reactions
  time frame: Baseline to 12 weeks
  description: Frequency, Intensity, Burden of Side Effects Rating (FIBSER) scale. Total scores range from 0-6 (3 items); cut-points are used to indicate moderate (score of 3) or severe (score of 5) adverse drug reaction/side effect interference with activities.
  measure: Percent Change in Role functioning
  time frame: Baseline to 12 weeks
  description: WHO Disability Assessment Schedule. Scores range from 0 to 48, with higher scores indicative of worse role functioning.
  measure: Percent Change in Depressive Symptom Severity
  time frame: Baseline to 12 weeks
  description: Quick Inventory of Depressive Symptomatology - Adolescent - 17-item (QIDS-A17). Scores range from 0-27, with higher scores indicative of more severe depression.
  measure: Percent Change in clinician assessment of depressive symptom severity
  time frame: Baseline to 12 weeks
  description: Change in Clinical Global Impression Severity (CGI-S) scale. Scores range from 0-7, with higher scores indicative of more severe illness.
  measure: Change in self-report health care resource use
  time frame: Baseline to 12 weeks
  description: Resource use questionnaire that captures number of visits and out-of-pocket costs for various mental health services.
  measure: Change in health care utilization
  time frame: Baseline to 12 weeks
  description: Administrative data will be obtained on medication information (agent, dose, duration) and health care utilization (doctor visits, hospitalizations, emergency room visits).
  measure: Change in health-related quality of life
  time frame: Baseline to 12 weeks
  description: EuroQoL 5 Dimension - Youth (EQ-5D-Y). Five descriptive items code level of perceived problems in health states and a visual analog scale has a score from 0-100, with higher scores indicative of better health.
  measure: Change in medication adherence
  time frame: 4 to 12 weeks
  description: Medication Adherence Report Scale (MARS-5) scores. Scores range from 5-25 with higher scores indicative of better medication adherence.
  measure: Change in behavioral activation
  time frame: Baseline to 12 weeks
  description: Emergence of activation based on Treatment-Emergent Activation and Suicidality Assessment Profile. Total scores range from 0-114 (38 items) with higher scores indicating greater behavioral activation.
  measure: Minimally clinically important differences
  time frame: 12 weeks
  description: Participant-reported, Global Rating of Change Scale (GRCS) (11-point Likert scale ranging from +5 to -5) to indicate the degree to which symptoms and role functioning changed for the better, for the worse, or no change was experienced.
  measure: Intervention fidelity
  time frame: 12 weeks
  description: Physician-reported, two-item questionnaire on use of recommendations in the dosing report.
  measure: Blinding fidelity
  time frame: 12 weeks
  description: Physician-reported, 1-item survey about the perceived allocation of each of their participating patients; response options are 'PGx-guided prescribing', 'don't know' or 'GLAD-PC prescribing'
  arm group label: Pharmacogenetic (PGx)-Guided
  arm group type: Experimental
  description: Participants and their physician will receive a one-time prescribing report after completing baseline for second-line selective serotonin reuptake inhibitors with dosing information based on CYP2B6, CYP2C19, and CYP2D6 genotype data.
  arm group label: Guidelines for Adolescent Depression in Primary Care (GLAD-PC)-Guided
  arm group type: Active Comparator
  description: Participants and their physician will receive a one-time prescribing report after completing baseline for second-line selective serotonin reuptake inhibitors based on GLAD-PC dosing guidelines.
  intervention type: Other
  intervention name: Pharmacogenetic-guided dosing
  description: SSRI dosing based on Clinical Pharmacogenetics Implementation Consortium's SSRI dosing guidelines.
  arm group label: Pharmacogenetic (PGx)-Guided
  intervention type: Other
  intervention name: GLAD-PC guided dosing
  description: SSRI dosing based on GLAD-PC clinical practice guidelines
  arm group label: Guidelines for Adolescent Depression in Primary Care (GLAD-PC)-Guided
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: 17 Years
  healthy volunteers: No
  last name: Chad Bousman, PhD
  role: Principal Investigator
  affiliation: University of Calgary
  last name: Amanda Newton, PhD
  role: Principal Investigator
  affiliation: University of Alberta
  last name: Laina McAusland, MSc
  phone: 403-210-6353
  email: gap@ucalgary.ca
  facility: 
  country: Canada
  responsible party type: Principal Investigator
  investigator affiliation: University of Calgary
  investigator full name: Chad Bousman
  investigator title: Associate Professor
  mesh term: Depression
  sharing ipd: Yes
  ipd description: Anonymized, individual participant PGx-GAP data will be shared using a controlled-access model. Under this model, the data will be released to a researcher if access criteria are met.
  All requests for data sharing should be made to the Co-Principal Investigators who will be responsible for reviewing and granting requests. Requestors should provide a research proposal for review. In the event that a data sharing request is declined, reasons will be provided to the requestor. If the data sharing request is granted, a data-sharing agreement will be initiated by the Co-Principal Investigators alongside the University of Calgary (lead institution). This agreement will include information on the individual data to be shared; if other documents will be available (e.g., statistical codes, data dictionary), when the data will be available and for how long, and how data access will be provided (e.g., file transfer).
  ipd access criteria: The requestor is affiliated with an academic institution as an independent investigator or trainee of an independent investigator;
  The proposed research question(s) and hypothesis(es) are specific, measurable, and achievable;
  The proposed research project will be governed/overseen by a local legal/regulatory body;
  The proposed research project poses no risk of invasion of privacy or breaches of confidentiality for trial participants;
  A member of the proposed research team has sufficient statistical skills to carry out the proposed analytic plan;
  The requestor has sufficient financial and/or human resources to see the proposed research project to completion;
  The proposed research question(s) and hypothesis(es) do not conflict with active or planned studies of the Co-Principal Investigators.