protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT03283735 | 9.1.1 | INFORMED CONSENT PROCESS | 9.1.1 INFORMED CONSENT PROCESS | [] |
NCT03283735 | 9.1.1.1 | CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO PARTICIPANTS | 9.1.1.1 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO PARTICIPANTS Consent forms describing in detail the study intervention, study procedures, and risks are given to the participant and written documentation of informed consent is required prior to starting intervention/administering study intervention. | [] |
NCT03283735 | 9.1.1.2 | CONSENT PROCEDURES AND DOCUMENTATION | 9.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION Informed consent is a process that is initiated prior to the individual's agreeing to participate in the study and continues throughout the individual's study participation. Consent forms will be IRB-approved and the participant will be asked to read and review the document.... | [] |
NCT03283735 | 9.1.2 | CONFIDENTIALITY AND PRIVACY | 9.1.2 CONFIDENTIALITY AND PRIVACY Information will be treated in strict confidentiality to protect the privacy of patients. The investigators will have no access to the data of the patient, except the one provided by the GP meaning that the only person to know who is being studied is the GP. Data will be electronically... | [] |
NCT03283735 | 9.1.3 | KEY ROLES AND STUDY GOVERNANCE | 9.1.3 KEY ROLES AND STUDY GOVERNANCE Principal Investigator Pedro Augusto Simões, Master degree, Doctor University of Beira Interior pedro.augusto.simoes@ubi.pt | [] |
NCT03283735 | 9.1.4 | PUBLICATION AND DATA SHARING POLICY | 9.1.4 PUBLICATION AND DATA SHARING POLICY The investigators will publish the results in peer-reviewed journal. There is no provision for data sharing. | [] |
NCT03283735 | 9.1.5 | CONFLICT OF INTEREST POLICY | 9.1.5 CONFLICT OF INTEREST POLICY The investigators don't have any conflict of interest. | [] |
NCT03283735 | 9.2 | ABBREVIATIONS | 9.2 ABBREVIATIONS | ANCOVA | Analysis of Covariance | | |--------|----------------------------------------------------|--| | ANOVA | Analysis of Variance | | | BMQ | Beliefs about Medicines Questionnaire | | | CI | Confidence Interval | | | EQ-5D | EuroQol Five Dimensions Questionnaire | | | GCP | Good Clinical Practic... | [] |
NCT03283735 | 9.3 | PROTOCOL AMENDMENT HISTORY | 9.3 PROTOCOL AMENDMENT HISTORY | Version | Date | Description of Change | Brief Rationale | |---------|------|-----------------------|-----------------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |... | [] |
NCT03283735 | 10 | REFERENCES | 10 REFERENCES - 1. Machado-Alba JE, Gaviria-Mendoza A, Machado-Duque ME, Chica L. Deprescribing: a new goal focused on the patient. Expert Opin Drug Saf. 2017;16(2):111-2. - 2. Scott IA, Hilmer SN, Reeve E, Potter K, Le Couteur D, Rigby D, et al. Reducing inappropriate polypharmacy: the process of deprescribing. JAMA I... | [] |
NCT03339219 | A | Phase 2, Open-Label, Single-Arm Study of Cabozantinib in Japanese Patients With Advanced Renal Cell Carcinoma That Has Progressed After Prior VEGFR Tyrosine Kinase Inhibitor Therapy | A Phase 2, Open-Label, Single-Arm Study of Cabozantinib in Japanese Patients With Advanced Renal Cell Carcinoma That Has Progressed After Prior VEGFR Tyrosine Kinase Inhibitor Therapy | [] |
NCT03339219 | A | Phase 2 Study of Cabozantinib in Japanese Patients with Advanced Renal Cell Carcinoma | A Phase 2 Study of Cabozantinib in Japanese Patients with Advanced Renal Cell Carcinoma
Amendment History: | | | PROTOCOL | ofmsTer | |------------------------------------------|--------------------|------------------------------------------------------------------------------------------------------------------------... | [
"Amendment History:",
"CONFIDENTIAL PROPERTY OF TAKEDA",
"1.0 ADMINISTRATIVE",
"1.1 Contacts",
"1.2 Approval",
"REPRESENTATIVES OF TAKEDA",
"SIGNATURES",
"1.3 Protocol Amendment 03 Summary of Changes",
"LIST OF APPENDICES",
"2.0 STUDY SUMMARY",
"Study Design:",
"Primary Objective:",
"Seconda... |
NCT03388970 | 1 | Background | 1 Background | [] |
NCT03388970 | 1.1 | spontaneous intracerebral hemorrhage | 1.1 spontaneous intracerebral hemorrhage | [] |
NCT03388970 | 1.1.1 | Epidemiological of cerebral hemorrhage | 1.1.1 Epidemiological of cerebral hemorrhage Cerebral hemorrhage is a kind of acute onset, rapid change, serious disease, which accounts for about 10%-25% of cerebrovascular disease, disability rate and fatality rate were 70%-80%, 38%-43%, the recurrence rate was about 1 1.8%-11%. Hypertension and amyloid cerebrovascul... | [] |
NCT03388970 | 1.2 | Introduction of vitamin K1 injections | 1.2 Introduction of vitamin K1 injections Vitamin K1 is an essential substance in the synthesis of prothrombin in the liver and can cause coagulation disorders when lacking. When the lack of prothrombin in the blood, blood coagulation will appear slow, then add appropriate amount of vitamin K1 can promote liver synthes... | [] |
NCT03388970 | 1.3 | Possible risks | 1.3 Possible risks Adverse reactions of vitamin K1: occasionally allergic reactions. Mainly occurs when the intravenous injection is too fast, more than 5mg/ minutes can cause facial flushing, sweating, bronchospasm, tachycardia, hypotension, etc., serious allergic reactions may endanger life. Intramuscular injection c... | [
".1.4. Benefits"
] |
NCT03388970 | 2 | Test purpose | 2 Test purpose The effectiveness and safety of vitamin K1 were mainly targeted at patients with cerebral hemorrhage (non aneurysm or vascular malformations, rupture, bleeding). To observe whether vitamin K1 can effectively avoid the increase of cerebral hemorrhage and improve the prognosis. | [] |
NCT03388970 | 3 | Test design | 3 Test design The study included spontaneous hypertensive intracerebral hemorrhage at super tentorium of cerebellum patients as the research object, to exclude cerebral aneurysms or cerebral hemorrhage, venous malformation of abnormal liver function, taking anticoagulants or antiplatelet drugs in patients. The study wa... | [] |
NCT03388970 | 4 | Subjects recruited and exited | 4 Subjects recruited and exited | [] |
NCT03388970 | 4.1 | Diagnostic criteria | 4.1 Diagnostic criteria | [] |
NCT03388970 | 4.1.1 | Diagnosis of cerebral hemorrhage | 4.1.1 Diagnosis of cerebral hemorrhage Referring to "Surgery"edited by Chen Xiaoping, and published in 2011 by people's Medical Publishing house. | [] |
NCT03388970 | 4.1.2 | Treatment methods | 4.1.2 Treatment methods According to "Neurosurgery of Wang Zhongcheng",conventional cerebral hemorrhage treatment. | [] |
NCT03388970 | 4.2 | Inclusion criteria | 4.2 Inclusion criteria - 1)Patients with spontaneous intracerebral hemorrhage (enhanced by cerebral arterial CT or cerebral angiography confirmed rupture of non aneurysm or arteriovenous malformation); - 3)Age 18-65 years, male or not pregnant female; - 4)GCS score at admission; - 5 ) Head CT or MRI examination confirm... | [] |
NCT03388970 | 4.3 | Exclusion criteria | 4.3 Exclusion criteria - 1)CT scan and irregular lobulated hematoma, such as intraventricular hemorrhage (because no accurate measurement of bleeding); - 2)Severe liver disease or impaired liver function; - 3)Pregnant or lactating women; - 4)The usage of anticoagulation or antiplatelet aggregation drug history (includi... | [] |
NCT03388970 | 4.4 | Rejection standard | 4.4 Rejection standard - 1)The subjects failed to meet the inclusion criteria and were mistakenly included in the trial. - 2)The subjects met either of the exclusion criteria. - 3)No record of any further visits. | [] |
NCT03388970 | 4.5 | Exit test standard | 4.5 Exit test standard | [] |
NCT03388970 | 4.5.1 | The researchers decided to quit | 4.5.1 The researchers decided to quit 1)During the clinical trial, the subjects experienced other complications, complications, or special physiological changes, and were not allowed to continue the experiment.. - 2)Serious adverse events and important adverse events, it is not appropriate to continue to accept the tes... | [] |
NCT03388970 | 4.5.2 | The subjects pulled out of their own accord | 4.5.2 The subjects pulled out of their own accord - 1)The subjects were unwilling or unable to continue clinical trials and asked the researchers for an exit test. - 2)The subjects were not explicitly asked to quit the trial, but those who were not receiving the medication and the test were lost. | [] |
NCT03388970 | 4.5.3 | Withdrawal case management | 4.5.3 Withdrawal case management In the case of the withdrawal from the trial, the researchers should actively take measures to complete the final examination as soon as possible to analyze the efficacy and safety. All trial cases should be completed in the case report form and the reasons for the withdrawal. | [] |
NCT03388970 | 5 | Suspension test standard | 5 Suspension test standard The discontinuation test means that the clinical trials have not been completed by the end of the program. The purpose of the suspension test is to protect the rights and interests of the subjects, to ensure the quality of the test and to avoid unnecessary economic losses. Standard for discon... | [] |
NCT03388970 | 7.3 | Follow-up visit | 7.3 Follow-up visit 1 months (+ 3 days) and 6 months (= 3 days) after the onset of intracerebral hemorrhage: the researchers performed a mRS score using telephone follow-up. | [] |
NCT03388970 | 7.4 | Unscheduled visit | 7.4 Unscheduled visit During the trial, unplanned visits should be made if the subject is unwell. | [] |
NCT03388970 | 7.5 | Test flow chart | 7.5 Test flow chart | Time point | (D0) | treatment | | | | vist | | | | | | |---------------------------|------|-----------|----|----|-----------|-----------|---------|--|--|--|--| | | | D1 | D3 | D7 | Discharge | The first | The six | | | | | | | | | | | or death | month | month | | | | | | Collect basic information ... | [] |
NCT03388970 | 7.5 | Concomitant medication and treatment | 7.5 Concomitant medication and treatment | [] |
NCT03388970 | 7.5.1 | Basic treatment | 7.5.1 Basic treatment Allow the cerebral hemorrhage treated with conventional therapy control of intracranial hypertension, prevention of complications, but it must be the case report form to record the medicine general or other treatment, dosage, reason, use frequency and time etc, so as to summarize, analyze and repo... | [] |
NCT03388970 | 7.5.2 | No medication or treatment | 7.5.2 No medication or treatment During the period of medication and during the follow-up period, drugs that affect the efficacy of the regimen may not be used, such as antithrombotic or anticoagulant or hemostatic drugs. | [] |
NCT03388970 | 7.5.3 | Medication and treatment are permitted | 7.5.3 Medication and treatment are permitted - ① The other combined diseases without affecting the curative effect and safety evaluation, can be symptomatic medication, but it must be the case report form to record the medicine general or other treatment, dosage, reason, use frequency and time etc, so as to summarize, ... | [] |
NCT03388970 | 8 | Therapeutic evaluation standard | 8 Therapeutic evaluation standard Main outcome measures: the amount of intracerebral hemorrhage (0d, 1D, 3D, 7D) at each time after the onset of disease. Main outcome measures: (1) the amount of the time changes in blood coagulation, platelet levels and GCS scores after the onset (0d, 1D, 3D, 7D); (2) days in ICU; (3) ... | [] |
NCT03388970 | 9 | Safety evaluation | 9 Safety evaluation | [] |
NCT03388970 | 9.1 | Definition | 9.1 Definition Adverse events (Adverse, Event, AE): refers to the patient or clinical trial subjects after receiving a drug adverse medical events, but not necessarily have a causal relationship with the treatment. Serious adverse events (Serious Adverse, Event, SAE): the need for hospitalization, prolonged hospitaliza... | [] |
NCT03388970 | 9.2 | Background data on safety associated with experimental drugs | 9.2 Background data on safety associated with experimental drugs The clinical adverse reactions include anxiety, skin itching, rash, nausea and stomachache, which can subside spontaneously after withdrawal. A small number of patients developed mental excitement and abnormal sleep. | [] |
NCT03388970 | 9.3 | Handling and recording of adverse events | 9.3 Handling and recording of adverse events | [] |
NCT03388970 | 9.3.1 | Treatment for adverse events | 9.3.1 Treatment for adverse events Inpatient If the subject has adverse events during hospitalization, follow the following procedures: Found adverse events in subjects, tube bed doctor or the doctor on duty shall promptly inform researchers, if necessary, can be the first symptomatic treatment, the degree of correlati... | [
"Outpatient"
] |
NCT03388970 | 9.3.2 | Record of adverse events | 9.3.2 Record of adverse events - ①A physician should perform a record of adverse events, including at least the description of the adverse events, the time of occurrence, the length of the termination, the frequency of attack, and the need for treatment and, if necessary, records of the treatment given. - ② In the orig... | [] |
NCT03388970 | 9.4 | Severe adverse events | 9.4 Severe adverse events | [] |
NCT03388970 | 9.4.1 | Treatment of severe adverse events | 9.4.1 Treatment of severe adverse events - ①In case of SAE, the first visit doctor shall notify the principal investigator or other doctors to be present. If it is serious, he or she shall notify the project leader when subjects are in danger; - ② As for the judgment of SAE, according to the clinical manifestations , p... | [] |
NCT03388970 | 9.4.2 | Severe adverse events are reported | 9.4.2 Severe adverse events are reported Researchers should give immediate rescue to serious adverse events occurred in the test , whether or not it is related to the study drug.The researchers should report to the relevant provinces, autonomous regions and municipalities directly under the drug supervision and adminis... | [] |
NCT03388970 | 9.4.3 | Hospitalization | 9.4.3 Hospitalization Adverse events leading to hospitalization or prolonged hospitalization in clinical trials should be considered as serious adverse events. Any first hospitalized (even shorter than 24 hours). Is according to comply with this standard.. Hospitalization does not include the following circumstances: R... | [] |
NCT03388970 | 9.5 | Grading of adverse events | 9.5 Grading of adverse events Mild: mild symptoms can be tolerated, does not affect activities of daily living, symptoms are transient, in the continuing use of drugs during their own relief, without treatment. Moderate: the symptoms are obvious, affecting the daily activities of the subjects, the symptoms for a long t... | [] |
NCT03388970 | 9.6 | Adverse events and test drug evaluation | 9.6 Adverse events and test drug evaluation According to the sequence between the occurrences of adverse drug evens and usage of drugs , the type of drug reaction after drug withdrawal reaction is reduced, will disappear or reappear, causality assessment of adverse events related to study drug is certainly relevant, pr... | [] |
NCT03388970 | 9.7 | Outcome tracking of adverse events | 9.7 Outcome tracking of adverse events Adverse events at the end of the study or not yet relieved must be followed until one of the following events occurs: - By accident mitigation; - Have stable event; when it is not possible to obtain other information (subjects or accompanying worker refuse to provide other informa... | [] |
NCT03559205 | 1 | BACKGROUND | 1 BACKGROUND Taken together, osteoarthritis, inflammatory disorders and common musculoskeletal conditions such as back, neck, shoulder, hip and knee pain now represent the single greatest cause of years lived with disability (1). Finding ways to prevent their impact on individuals' quality of life is a significant and ... | [] |
NCT03559205 | 2 | RATIONALE | 2 RATIONALE The Arthritis Research UK Musculoskeletal Health Questionnaire (MSK-HQ) is a recently validated new MSK Patient Reported Outcome Measure (PROM) that has been co-produced with patients and clinicians to measure the holistic impact of an MSK condition on a person's health. It has been validated in both primar... | [] |
NCT03559205 | 3 | OBJECTIVES AND OUTCOME MEASURES/ENDPOINTS | 3 OBJECTIVES AND OUTCOME MEASURES/ENDPOINTS | [] |
NCT03559205 | 3.1 | Primary objective | 3.1 Primary objective The overall focus of this research is to co-design and test the feasibility and impact of implementing the MSK-HQ presented within an innovative online care planning package called the MSK-Tracker. | [] |
NCT03559205 | 3.2 | Secondary objectives | 3.2 Secondary objectives - a) To optimise the acceptability and utility of the MSK-Tracker as a self-management support tool for patients to use to take control of their MSK health issues and facilitate personal goal setting during MSK clinical encounters - b) To assess the feasibility and utility of the MSK-Tracker in... | [] |
NCT03559205 | 3.3 | Primary endpoint/outcome | 3.3 Primary endpoint/outcome A measure of patient empowerment - the patient enablement scale (40), will be the primary outcome in this study and will be captured using an online e-PROM. The primary end-point will be the 2 week post-consultation measure, although the measure will also be included in the 3 month follow-u... | [] |
NCT03559205 | 3.4 | Secondary endpoints/outcomes | 3.4 Secondary endpoints/outcomes We will collect a range of patient self-report characteristics to be able to describe the patient population such as; age, gender, ethnicity, education level, work status, health literacy, MSK pain site/condition, and episode duration. Secondary outcome measures will include further cli... | [] |
NCT03559205 | 4 | STUDY DESIGN | 4 STUDY DESIGN The study is using a 'before' and 'after' sequential comparison design with an iterative pilot and user testing phase in between. In addition, audio recordings of the consultation (in a sub-sample, n=40 (phase 1=20 & phase 3=20)), alongside individual clinician and patient interviews and a feedback works... | [] |
NCT03559205 | 4.1 | Interventions/Treatments | 4.1 Interventions/Treatments The intervention is not a treatment per se, but involves patients and clinicians engaging with the MSK-Tracker software. It is envisaged that the MSK-Tracker will facilitate a new care planning approach with the following distinct components: - Pre-clinic preparation. Prior to a consultatio... | [] |
NCT03559205 | 4.2 | Study Training | 4.2 Study Training Clinicians involved in the study will undergo training in the use of the online e-PROM and full MSK-Tracker functionality (depending on the study phase). They will also have time to discuss the benefits of involving the patient's agenda within the consultation, and to practice ways that are built int... | [] |
NCT03559205 | 5 | STUDY SETTING | 5 STUDY SETTING The study will take place in participating NHS MSK clinical sites. These services assess patients over the age of 18 with non-inflammatory and non-surgical musculoskeletal disease. They accept referrals from general practitioners and physiotherapists. They assess and diagnose a patient's musculoskeletal... | [] |
NCT03559205 | 6 | ELIGIBILITY CRITERIA | 6 ELIGIBILITY CRITERIA | [] |
NCT03559205 | 6.1 | Inclusion criteria | 6.1 Inclusion criteria Patients aged 18 years and above with an appointment at one of the participating services for an MSK pain problem will be invited to take part. | [] |
NCT03559205 | 6.2 | Exclusion criteria | 6.2 Exclusion criteria Patients unable to use or access the internet will be unable to take part in this research as well as patients who do not provide informed consent for study participation and data collection. The online system will only be available in English. | [] |
NCT03559205 | 7 | STUDY PROCEDURES | 7 STUDY PROCEDURES | [] |
NCT03559205 | 7.1 | Recruitment | 7.1 Recruitment Patients will be recruited at participating NHS MSK clinical sites. | [] |
NCT03559205 | 7.1.1 | Patient identification | 7.1.1 Patient identification Patients with an upcoming appointment to attend for an MSK pain problem at a participating site will be sent an invitation letter and patient information leaflet (either by email or post) informing them of the research at least 48 hours before their appointment date. The letter sent will co... | [] |
NCT03559205 | 7.2 | Consent | 7.2 Consent
Consent - main study Consent will be taken online through the e-PROM platform. If after reading the invitation letter and patient information leaflet the patient wishes to take part in the research, they will visit the website and enter the unique study ID provided in the invitation letter. The patient wil... | [
"Consent - main study",
"Consent - consultation recording",
"Consent - interviews"
] |
NCT03559205 | 7.3 | Baseline data | 7.3 Baseline data During all phases of the study, patients will complete a baseline assessment within the electronic survey prior to attending clinic. The assessment consists of the MSK-HQ, Consumer Health Activation Index, and demographic information including age, gender, work status, site of main presenting MSK prob... | [] |
NCT03559205 | 7.4 | Follow up data at 2 weeks | 7.4 Follow up data at 2 weeks Patients will complete an assessment using the e-PROM/MSK-Tracker 2 weeks after their clinic appointment. See Table 1 (page 20) for details of the assessment questions.  | [] |
NCT03559205 | 7.5 | Follow up data at 3 months | 7.5 Follow up data at 3 months Patients will complete a further and final assessment 3 months after their clinic appointment. See Table 1 below for details of the assessment questions. Table 1: Patient survey variables | Variable name | Frequency (Baseline / 2 Weeks /3 Months) | | |-------------------------------------... | [] |
NCT03559205 | 7.6 | Qualitative assessments – Nested studies | 7.6 Qualitative assessments – Nested studies There are four different sections of qualitative research within the study: - 1. To contribute directly to the iterative user testing in phase 2 - 2. To explore how the MSK-Tracker changes the nature of consultation conversations - 3. To interview patients and clinicians abo... | [] |
NCT03559205 | 7.6.1 | To contribute directly to the iterative user testing in Phase 2 | 7.6.1 To contribute directly to the iterative user testing in Phase 2 During phase 2 of the project we aim to optimise the MSK-Tracker through an iterative user testing process with patients, clinicians, software provider, and experts. The purpose of this phase is to identify specific difficulties people have with usin... | [
"Recruitment during Phase 2 (at first clinical site only)",
"Method",
"Cycle 1",
"Analysis"
] |
NCT03559205 | 7.6.2 | To explore how the MSK-Tracker changes the nature of consultation conversations | 7.6.2. To explore how the MSK-Tracker changes the nature of consultation conversations To evaluate the impact of the MSK-Tracker on the consultation in respect to the focus of what is discussed with the patient, we will use audio recordings of a purposive sample of approximately 20 consultations from Stage 1 and again ... | [] |
NCT03559205 | 7.6.3 | Individual interviews with patients and clinicians to explore experiences of the MSK-Tracker | 7.6.3. Individual interviews with patients and clinicians to explore experiences of the MSK-Tracker Baseline patient interviews in phase 1 will establish a baseline and map current experiences of clinic consultations and patient empowerment through supported self-management. The experience based co design (EBCD) (refer... | [
"Follow up interviews in Phase 3",
"With clinicians:",
"With patients:"
] |
NCT03559205 | 7.6.4 | To explore how MSK-Tracker aggregated data informs service quality improvement | 7.6.4. To explore how MSK-Tracker aggregated data informs service quality improvement It is anticipated that the MSK-Tracker, as well as empowering patients, will be useful for generating aggregated feedback about what matters to patients that MSK Service providers (and potentially commissioners) can use to support con... | [] |
NCT03559205 | 7.7 | Withdrawal criteria | 7.7 Withdrawal criteria Patients can withdraw at any time. Withdrawal will mean no further reminders or emails to complete online questionnaires will be sent. Any information provided up to the point they withdraw will be used unless the patients asks for their data to be destroyed. | [] |
NCT03559205 | 7.8 | End of study | 7.8 End of study The study end point is either when the last participant recruited in phase 3 completes their 3 month follow up, or the final qualitative interview or workshop is completed (whichever is last). | [] |
NCT03559205 | 8 | STATISTICS AND DATA ANALYSIS | 8 STATISTICS AND DATA ANALYSIS | [] |
NCT03559205 | 8.1 | Sample size calculation | 8.1 Sample size calculation The primary outcome of this trial is the patient enablement instrument (PEI) at 2 week follow up. As patients are asked to retrospectively rate the level of enablement, at the 2-week follow up, as a result of their visit to the Staffordshire Musculoskeletal Interface Service we only have a s... | [] |
NCT03559205 | 8.2 | Planned recruitment rate | 8.2 Planned recruitment rate The target recruitment will be 200 participants (in both phase 1 and phase 3. | [] |
NCT03559205 | 8.3 | Statistical analysis plan | 8.3 Statistical analysis plan Initially, descriptive data will characterise the study sample. A descriptive statistical analysis will provide estimates of the extent to which, between phase 1 and phase 3, the use of the MSK-Tracker changed the content and time spent on topics of patient concern in the clinic consultati... | [] |
NCT03559205 | 9 | DATA HANDLING | 9 DATA HANDLING 9.1 Data within the MSK-Tracker is to be captured through secure online forms ensuring that all regulatory requirements are met, including the new General Data Protection Regulation (GDPR), NHS Information Governance, and GCP. The secure servers will be operated using SSL secure environments and all bas... | [] |
NCT03559205 | 9.2 | Data Sharing Agreements | 9.2 Data Sharing Agreements Keele (Clinical Trials Unit) CTU is committed to sharing access to our anonymised research databases derived from our population, consultation, clinical, and RCT cohorts. Any requests for access to the anonymised data from anyone outside of the study team (e.g. collaboration, joint publicati... | [] |
NCT03559205 | 9.3 | Data Archiving | 9.3 Data Archiving At the end of the study, data will be securely archived in line with the Sponsor's procedures for a minimum of 10 years after the publication of the study findings. A record of consent will be held in the local investigator site file. All other data will be held by Keele CTU and will be archived in t... | [] |
NCT03559205 | 10 | MONITORING & AUDIT | 10 MONITORING & AUDIT | [] |
NCT03559205 | 10.1 | Study Management | 10.1 Study Management The study will be managed by Keele Clinical Trials Unit (CTU) adhering to its Standard Operating Procedures. The trial manager will convene a Study Management Group consisting of the study lead (Hill), all the co-applicants including the PPIE member, those from Oxford and the external partners. Mo... | [] |
NCT03559205 | 10.2 | Safety Reporting | 10.2 Safety Reporting The NHS Health Research Authority (HRA) definition of a Serious Adverse Event (SAE) is an untoward occurrence during the conduct of the study that: - results in death; - is life-threatening; - requires hospitalisation or prolongation of existing hospitalisation; - results in persistent or signific... | [] |
NCT03559205 | 10.3 | Trial timeline | 10.3 Trial timeline  | [] |
NCT03559205 | 11 | ETHICAL AND REGULATORY CONSIDERATIONS | 11 ETHICAL AND REGULATORY CONSIDERATIONS This study will be submitted for approval by an appropriate NHS Research Ethics Committee and to the Health Research Authority (HRA). It will also be submitted for inclusion within the National Institute for Health Research (NIHR) Clinical Research Network (CRN) Portfolio. Patie... | [] |
NCT03559205 | 11.2 | Peer review | 11.2 Peer review An external scientific panel reviewed the study funding proposal on behalf of the Arthritis Research UK, Health Service Research award panel. As a result the study has had extensive peer review as part of that 2-stage application process. For example, we were asked to strengthen the justification for o... | [] |
NCT03559205 | 11.3 | Public and Patient Involvement | 11.3 Public and Patient Involvement The Research Institute for Primary Care & Health Sciences at Keele University has a strong Patient and Public involvement and Engagement (PPIE) infrastructure, supported by Arthritis Research UK Centre of Excellence funding, which includes a large Research User Group (RUG) advising o... | [
"Ongoing PPIE"
] |
NCT03559205 | 11.4 | Regulatory Compliance | 11.4 Regulatory Compliance Data within the MSK-Tracker is to be captured through secure online forms that meet NHS Information Governance requirements. Patient data (in an electronic format) will be acquired, anonymised, transferred and stored according to the General Data Protection Regulation (GDPR) (Regulation (EU) ... | [] |
NCT03559205 | 11.5 | Protocol compliance | 11.5 Protocol compliance Deviations from study protocols and Good Clinical Practice (GCP) occur commonly in health and social care research. The majority of these instances are technical non-compliances that do not result in harm to the trial subjects, do not compromise data integrity, or significantly affect the scien... | [] |
NCT03559205 | 11.6 | Data protection and patient confidentiality | 11.6 Data protection and patient confidentiality See section 9.1 for details of how data is protected and patient confidentiality maintained throughout this study. | [] |
NCT03559205 | 11.7 | Financial and other competing interests for the chief investigator, PIs at each site and committee members for the overall study management | 11.7 Financial and other competing interests for the chief investigator, PIs at each site and committee members for the overall study management Professor Andrew Price (co-applicant on this grant) is the Chief Executive of PRO-MAPP and is remunerated for his directorship. | [] |
NCT03559205 | 11.8 | Access to the final study dataset | 11.8 Access to the final study dataset See section 9.2 | [] |
NCT03559205 | 12 | DISSEMINATION POLICY | 12 DISSEMINATION POLICY | [] |
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