chufangao/CTO huggingface dataset:
Clinical trial NCT03264989: Pharmacokinetics and Pharmacodynamics Study of SEG101 (Crizanlizumab) in Sickle Cell Disease (SCD) Patients With Vaso- Occlusive Crisis (VOC)
Official title: A Phase 2, Multicenter, Open-Label Study to Assess PK/PD of SEG101 (Crizanlizumab), With or Without Hydroxyurea/Hydroxycarbamide, in Sickle Cell Patients With Vaso-Occlusive Crisis
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 57.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-12-19
Primary completion date: 2023-06-26
Completion date: 2023-06-26
Baseline population: Full Analysis Set (FAS): Consisted of all patients to whom crizanlizumab had been assigned and who received at least 1 dose of study treatment.
Limitations and caveats: This study provided a 5-year follow up (f/u) data that fully characterized the safety, tolerability \& treatment of the 5.0 mg/kg \& 7.5 mg/kg doses of crizanlizumab along with the initially planned PK \& PD data. As the goal of study f/u was reached, study was considered completed \& it was in line with the end of study as defined in the study protocol, the sponsor closed the study as the participants were no longer receiving intervention or being examined.
Plan to share individual participant data: YES
IPD sharing description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Clinical trial NCT04268303: Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia
Official title: A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Determine Efficacy and Safety of BXCL501 In Agitation Associated With Schizophrenia
Acronym: SERENITY I
Sponsor: BioXcel Therapeutics Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 380.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-01-24
Primary completion date: 2020-05-06
Completion date: 2020-05-06
Baseline population: Safety population (all participants who received study drug). One participant enrolled and randomized to the 120 μg group was enrolled a second time at a different site and randomized to the 180 μg group. The data from the first enrollment and treatment (120 μg) were included in the efficacy analyses. The data from both enrollments (120 μg and 180 μg) were included in the safety analyses and counted separately for each treatment group.
Plan to share individual participant data: NO
Clinical trial NCT04988087: A Study to Evaluate the Safety, Tolerability and Efficacy of MHV370 in Participants With Sjogren's Syndrome (SjS) or Mixed Connective Tissue Disease (MCTD)
Official title: A Multi-center, Randomized, Participant- and Investigator- Blinded, Placebo-controlled, Parallel Group Basket Study to Evaluate the Safety, Tolerability and Efficacy of MHV370 in Participants With Sjögren's Syndrome or Mixed Connective Tissue Disease
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 30.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-11-30
Primary completion date: 2023-02-07
Completion date: 2023-03-07
Plan to share individual participant data: YES
IPD sharing description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Clinical trial NCT03047330: Menopausal Sleep Fragmentation and Body Fat Gain
Official title: Menopausal Sleep Fragmentation: Impact on Body Fat Gain Biomarkers in Women
Sponsor: Brigham and Women's Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 41.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-07-15
Primary completion date: 2022-08-01
Completion date: 2022-08-01
Clinical trial NCT04001647: Targeting ER Stress in Vascular Dysfunction
Official title: Targeting Endoplasmic Reticulum Stress in Aging- and Obesity-Induced Vascular Dysfunction
Sponsor: Colorado State University (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: IRB approval has been withdrawn
Enrollment: 17.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-01
Primary completion date: 2022-08-16
Completion date: 2022-08-16
Plan to share individual participant data: NO
Clinical trial NCT04003896: A Study to Evaluate Abemaciclib in Advanced Biliary Tract Carcinoma
Official title: A Pilot Study to Evaluate the Response and Tolerability of Verzenio (Abemaciclib) in Patients With Advanced Biliary Tract Carcinoma
Sponsor: Milton S. Hershey Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The manufacturer and funder Eli Lilly requested to terminate the study
Enrollment: 4.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-09-24
Primary completion date: 2023-08-15
Completion date: 2023-08-15
Baseline population: The baseline analysis population includes all participants who were enrolled in the study before it was terminated. In this case, the study enrolled a total of 4 participants out of the planned 10.
Limitations and caveats: Early termination leading to small numbers of subjects analyzed.
Clinical trial NCT03710915: A Study of HG146 Capsule in Chinese Subjects with Relapsed and Refractory Multiple Myeloma
Official title: A Phase I Study of Single-centre, Open-label Clinical Trial to Evaluate HG146 Capsule in the Treatment of Relapsed and Refractory Multiple Myeloma
Sponsor: HitGen Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Company decision
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-01-12
Primary completion date: 2022-09-28
Completion date: 2023-06-28
Plan to share individual participant data: NO
Clinical trial NCT04820530: Study of Efficacy and Safety of Twice Daily Oral Iptacopan (LNP023) in Adult PNH Patients Who Are Naive to Complement Inhibitor Therapy
Official title: A Multicenter, Single-arm, Open-label Trial to Evaluate Efficacy and Safety of Oral, Twice Daily Iptacopan in Adult PNH Patients Who Are Naive to Complement Inhibitor Therapy
Acronym: APPOINT-PNH
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 40.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-07-19
Primary completion date: 2022-11-02
Completion date: 2023-04-18
Plan to share individual participant data: YES
IPD sharing description: Novartis is committed to sharing with qualified external researchers, access to patient level data and supporting clinical documents from eligible studies. these requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Clinical trial NCT04711902: Study of Efficacy and Safety of Secukinumab in Chinese Subjects With Active PsA Compared to Placebo.
Official title: A Phase III Randomized, Double-blind, Placebo Controlled, Multicenter, Bridging Study of Subcutaneous Secukinumab, to Demonstrate Efficacy After Sixteen Weeks of Treatment and to Assess Safety, Tolerability and Long-term Efficacy Follow-up to One Year in Chinese Subjects With Active Psoriatic Arthritis
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 41.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-06-24
Primary completion date: 2022-06-02
Completion date: 2023-03-10
Baseline population: Randomized set: All participants who were randomized.
Plan to share individual participant data: YES
IPD sharing description: Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Clinical trial NCT05193604: A Clinical Trial to Evaluate Tolerability and Security of TQB2858 Injection in Subjects With Advanced Pancreatic Carcinoma
Official title: Phase I Clinical Trial to Evaluate the Tolerability and Safety of TQB2858 Injection in Subjects With Metastatic Pancreatic Cancer
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Terminated due to the adjustment of sponsor's development strategies and pipeline.
Enrollment: 29.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-03-24
Primary completion date: 2023-11-27
Completion date: 2023-11-27
Clinical trial NCT04846231: Supplements, Placebo, or Rosuvastatin Study
Official title: Supplements, Placebo, or Rosuvastatin Study
Acronym: SPORT
Sponsor: The Cleveland Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 203.0 (ACTUAL)
Number of arms: 8.0
Start date: 2021-04-23
Primary completion date: 2022-07-19
Completion date: 2022-07-19
Plan to share individual participant data: NO
Clinical trial NCT06084351: Phase 3 Open-Label Controlled Trial of Convalescent Plasma in Early COVID-19 Infection
Official title: Phase 3 Open-Label Controlled Trial of Convalescent Plasma in Early COVID-19 Infection
Sponsor: Larkin Community Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Study Period Ended / Not Completed
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-12
Primary completion date: 2020-10-30
Completion date: 2020-10-30
Clinical trial NCT04168931: Trastuzumab to Patients With Advanced Gastric Cancer With HER2 Positive Expression in CTC
Official title: Efficacy of Adding Trastuzumab to Standard Chemotherapy in Patients With Advanced HER2-negative Gastric Cancer and HER2 Positive Expression in Circulating Tumor Cells
Acronym: GASTHER2
Sponsor: AC Camargo Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: recruitment failure
Enrollment: 5.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-01-01
Primary completion date: 2023-01-13
Completion date: 2023-01-13
Plan to share individual participant data: NO
Clinical trial NCT03020589: Study of Pharmacogenomic-Guided Tacrolimus Dosing and Monitoring in Kidney Transplant Recipients
Official title: Study of Pharmacogenomic-Guided Tacrolimus Dosing and Monitoring in Kidney Transplant Recipients
Acronym: TAC3A5
Sponsor: University of North Carolina, Chapel Hill (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 97.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-02-06
Primary completion date: 2021-07-31
Completion date: 2022-06-28
Plan to share individual participant data: NO
IPD sharing description: No participant data will be shared outside the research team.
Clinical trial NCT06365918: Study of VG2025 Delivered Intraperitoneally in Patients with Advanced Solid Tumors with Carcinomatosis
Official title: Phase I Study of VG2025 Delivered Intraperitoneally in Patients with Advanced Solid Tumors with Carcinomatosis
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: PI Request
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2024-09-30
Primary completion date: 2024-10-02
Completion date: 2024-10-02
Plan to share individual participant data: NO
Clinical trial NCT03220347: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CC-90010 in Subjects With Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin's Lymphomas
Official title: A Phase 1, Open-label, Dose-finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CC-90010 in Subjects With Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin's Lymphomas
Sponsor: Celgene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Business objectives have changed
Enrollment: 139.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-07-24
Primary completion date: 2024-09-06
Completion date: 2024-09-06
Plan to share individual participant data: NO
Clinical trial NCT01427114: R-CVP for the Treatment of Non-conjunctival Ocular Adnexal MALT Lymphoma (OAML)
Official title: Open-labeled, Multicenter Phase II Study of Rituximab, Cyclophosphamide, Vincristine, and Prednisolone (R-CVP) Chemotherapy in Patients With Non-conjunctival Ocular Adnexal MALT Lymphoma
Sponsor: Konkuk University Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 33.0 (ACTUAL)
Number of arms: 1.0
Start date: 2011-07-01
Primary completion date: 2014-08-01
Completion date: 2021-01-01
Clinical trial NCT04707313: A Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Obesity
Official title: A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-06882961 ADMINISTRATION IN ADULTS WITH OBESITY
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 628.0 (ACTUAL)
Number of arms: 13.0
Start date: 2021-01-29
Primary completion date: 2023-09-13
Completion date: 2023-10-11
Baseline population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Plan to share individual participant data: YES
IPD sharing description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Clinical trial NCT03766607: Trastuzumab Beyond Progression in HER2 Positive Metastatic Gastric Cancer
Official title: A Multi-center Phase II Study of Trastuzumab Biosimilar (SB3®) in Combination With Ramucirumab and Paclitaxel in HER2 Positive Metastatic Gastric Cancer Patients
Sponsor: Korean South West Oncology Group (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Competing other studies
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-09-30
Primary completion date: 2021-12-31
Completion date: 2022-06-30
Plan to share individual participant data: NO
Clinical trial NCT05492851: Trial Comparing Three Single Dose Injections for Knee Osteoarthritis
Official title: A Double-blind, Randomized Trial Comparing Three Single Dose Injections for Knee Osteoarthritis
Sponsor: Ohio State University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: The study has only enrolled 6 subjects in 6 months since study initiation. Potential participants are unwilling to participate in the study due to the randomziation and blinding. Both aspects are needed to ensure a robust comparison between groups.
Enrollment: 6.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-08-02
Primary completion date: 2023-01-11
Completion date: 2023-01-11
Plan to share individual participant data: NO
IPD sharing description: IDP will not be shared.
Clinical trial NCT04837482: A Study to Assess the Impact and Adverse Events of Topical Eyedrops of AGN-190584 on Night-driving Performance in Participants, 40 to 55 Years of Age
Official title: Evaluating the Impact of AGN-190584 on Night-driving Performance
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 43.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-05-14
Primary completion date: 2021-12-07
Completion date: 2021-12-07
Baseline population: The ITT population includes all randomized participants.
Plan to share individual participant data: YES
IPD sharing description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD time frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Clinical trial NCT04847141: A Study to Evaluate the Safety and Efficacy of C19-IG 20% in SARS-CoV-2 Infected Asymptomatic Ambulatory Outpatients
Official title: A Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Safety and Efficacy of Anti-COVID-19 Immune Globulin (Human) 20% (C19-IG 20%) Versus Placebo in Asymptomatic Ambulatory Outpatients With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection
Acronym: COVID-19
Sponsor: Grifols Therapeutics LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Study Stopped for Futility
Enrollment: 465.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-04-28
Primary completion date: 2021-11-10
Completion date: 2021-12-27
Baseline population: Intent-to-treat (ITT) population included all participants who were randomized. Modified ITT (mITT) population included the subset of ITT participants who were also dosed.
Limitations and caveats: The study was terminated for futility.
Plan to share individual participant data: NO
Clinical trial NCT03879798: DS-3201b and Irinotecan for Patients With Recurrent Small Cell Lung Cancer
Official title: A Phase I/II Study of DS-3201b, an EZH1/2 Inhibitor, in Combination With Irinotecan in Patients With Recurrent Small Cell Lung Cancer
Sponsor: Memorial Sloan Kettering Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Due to DLTs
Enrollment: 22.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-03-15
Primary completion date: 2023-05-02
Completion date: 2023-05-02
Baseline population: Participants were not treated at Dose Level 3, 4 or 5
Plan to share individual participant data: YES
IPD sharing description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Clinical trial NCT04181762: Study of Safety, Efficacy and Tolerability of Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis
Official title: A Two-year, Phase III Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Evaluate the Safety, Efficacy, and Tolerability of 300 mg s.c. Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis
Acronym: SELUNE
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Study terminated by sponsor due to futility analysis
Enrollment: 275.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-07
Primary completion date: 2023-09-13
Completion date: 2023-09-13
Plan to share individual participant data: YES
IPD sharing description: Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Clinical trial NCT05542355: EXL01 in the Maintenance of Steroid-induced Clinical Response/Remission in Participants With Mild to Moderate Crohn's Disease
Official title: A Phase 1, Multicentre, 2-Part, Randomised, Parallel-arm, Placebo-controlled, Partially Double-blind Study to Evaluate the Safety and Target Engagement of EXL01 in the Maintenance of Steroid-induced Clinical Response or Remission in Participants With Mild to Moderate Crohn's Disease
Acronym: MAINTAIN
Sponsor: Exeliom Biosciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Due to low recruitment
Enrollment: 8.0 (ACTUAL)
Number of arms: 3.0
Start date: 2023-03-20
Primary completion date: 2024-10-02
Completion date: 2024-10-02
Plan to share individual participant data: NO
Clinical trial NCT03893565: Safety, Tolerability, Efficacy and Dose-response of GSK2831781 in Ulcerative Colitis
Official title: A Multicentre Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Safety, Tolerability, Efficacy, Dose-response, Pharmacokinetics and Pharmacodynamics of Repeat Dosing of an Anti-LAG3 Cell Depleting Monoclonal Antibody (GSK2831781) in Patients With Active Ulcerative Colitis
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The trial was stopped based on the assessment of clinical data.
Enrollment: 104.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-05-06
Primary completion date: 2021-05-17
Completion date: 2021-05-17
Plan to share individual participant data: YES
IPD sharing description: IPD for this study will be made available via the Clinical Study Data Request site.
IPD time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
IPD access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.