protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT03595618 | 6.1.3 | Management of blinding systems | 6.1.3. Management of blinding systems The patient treatment code should only be broken in case of emergency where the further treatment of the patient is dependent on the treatment he or she is receiving. In the cases where the blind needs to be broken by the investigators for imperative justified medical reason, a cen... | [] |
NCT03595618 | 6.2 | IMPs administered | 6.2. IMPs administered No IMPs will be administered during screening and follow up periods. From the day of inclusion until the W052 Visit, the patient will take four (4) tablets orally once a day with a glass of water preferably in the morning (at the same time), corresponding to: - S201086/GLPG1972 75 mg/day: 1 table... | [] |
NCT03595618 | 6.3 | IMPs dispensing | 6.3. IMPs dispensing Investigator and/or the pharmacist of the medical institution and / or a designated person from their study team will use the IWRS, as described in the IWRS manual, to perform the following actions: - To create the patient number at ASSE visit, - To randomize the patient and allocate the treatment ... | [] |
NCT03595618 | 6.4 | IMP compliance | 6.4. IMP compliance The number of tablets dispensed and the number of tablets returned by the patient are to be counted by the investigator or a designated person from his/her team and recorded in the electronic case report form and therapeutic unit tracking form, or an equivalent document. If the patient did not bring... | [] |
NCT03595618 | 6.5 | Discontinuation of the IMP | 6.5. Discontinuation of the IMP After the discontinuation of the IMP, the patients' treatment is left to the physician's discretion. As the study drug is not on the market, it will not be available. Specific rules may be followed in some countries according to local regulation. | [] |
NCT03595618 | 6.6 | Previous and concomitant treatments | 6.6. Previous and concomitant treatments Previous treatments are all treatments stopped within 6 months before screening visit; concomitant treatments are treatments ongoing at screening visit as well as new treatments initiated during the study. Previous and concomitant treatment (prescriptions or over-the-counter med... | [
"Type of treatment",
"Type of treatment"
] |
NCT03595618 | 7 | ASSESSMENT OF EFFICACY | 7. ASSESSMENT OF EFFICACY | [] |
NCT03595618 | 7.1 | Efficacy measurements | 7.1. Efficacy measurements Efficacy measurements performed during the study are indicated in Table (4.2.2) 1. | [] |
NCT03595618 | 7.2 | Methods and measurement times | 7.2. Methods and measurement times | [] |
NCT03595618 | 7.2.1 | Medical imaging | 7.2.1. Medical imaging Before their participation in the study CL2-201086-002/GLPG1972-CL-201, all centers will receive a specific training/qualification coordinated by the CRO in charge of medical imaging management (MRI qualification protocol). In addition, this CRO will be in charge of: - o Imaging (MRI and X-ray) r... | [
"o qMRI:",
"o Radiography (X-ray):"
] |
NCT03595618 | 7.2.2 | WOMAC for measurement of pain, function and stiffness (Appendix 2) | 7.2.2. WOMAC for measurement of pain, function and stiffness (Appendix 2) The WOMAC index score will be assessed on site at W000, W012, W028, W040, W052 and if applicable at the withdrawal visit (WD). WOMAC (version LK3.1, copyright holder Nicholas Bellamy) is a questionnaire designed to assess health status and health... | [] |
NCT03595618 | 7.2.3 | VAS for pain intensity (Appendix 3) | 7.2.3. VAS for pain intensity (Appendix 3) After the choice of the target knee to be followed throughout the study has been made by the investigator and explained to the patient, the pain intensity will be assessed during each visit (ASSE on both knees and W000, W004, W008, W012, W020, W028, W040, W052 and WEND on the ... | [] |
NCT03595618 | 7.2.4 | VAS for Patient Global Assessment of disease activity (PGA) (Appendix 4) | 7.2.4. VAS for Patient Global Assessment of disease activity (PGA) (Appendix 4) The PGA VAS will be assessed during the following visits: W000 (inclusion), W012, W028, W040, W052 and if at the withdrawal visit (WD) by the patient him/herself by marking the level of "Considering all the ways in which your knee osteoarth... | [] |
NCT03595618 | 7.2.5 | Analgesic consumption | 7.2.5. Analgesic consumption Drug analgesic consumption of the patient will be recorded on the eCRF at W000 (inclusion), W004, W008, W012, W020, W028, W040, W052, WEND and if applicable at the withdrawal visit (WD). | [] |
NCT03595618 | 8 | SAFETY MEASUREMENTS | 8. SAFETY MEASUREMENTS All AEs and other situations relevant to the safety of the patients must be followed up and fully and precisely documented in order to ensure that the sponsor has the necessary information to continuously assess the benefit-risk balance of the clinical study. | [] |
NCT03595618 | 8.1 | Specification of safety parameters | 8.1. Specification of safety parameters Safety measurements performed during the study are indicated in Table (4.2.2) 1. The safety will be assessed based on of the following information: - AEs - Physical assessment including knees - Vital signs - Assessment with automatic blood pressure monitoring of: - o Systolic blo... | [] |
NCT03595618 | 8.2 | Methods and measurement times | 8.2. Methods and measurement times Vital signs will be evaluated at ASSE, W000, W004, W008, W012, W020, W028, W040, W052, WEND and if applicable at the premature withdrawal visit (WD). Blood pressure will be measured with automatic blood pressure monitor and will preferably be measured on the same arm (in case of equip... | [] |
NCT03595618 | 8.3 | Definition of Adverse events | 8.3. Definition of Adverse events An AE is defined as any untoward medical occurrence in a patient participating in a clinical study, whether or not there is a causal relationship with the IMP and/or experimental procedures, occurring or detected from the date the patient signs the information and consent form, irrespe... | [
"Of note:"
] |
NCT03595618 | 8.4 | Definition of Serious adverse events | 8.4. Definition of Serious adverse events Any AE that at, any dose: - results in death, - is life-threatening(1) , - requires inpatient hospitalization or prolongation of existing hospitalization, - results in persistent or significant disability/incapacity(2) , - is a congenital anomaly/birth defect(3) , - is medicall... | [] |
NCT03595618 | 8.5 | Definition of special situations | 8.5. Definition of special situations - Pregnancy of participant or partner of male participant in the study - Other special situations:
Abuse of study drug The persistent or sporadic, intentional excessive use of the study drug, which is accompanied by harmful physical or psychological effects.
Misuse of study drug ... | [
"Abuse of study drug",
"Misuse of study drug",
"Drug interaction with study drug",
"Food interaction with study drug",
"Medication error",
"Occupational exposure",
"Overdose",
"Product complaint or quality defect of study drug"
] |
NCT03595618 | 8.6 | Definition of Adverse event of special interest | 8.6. Definition of Adverse event of special interest At the time of writing this study protocol, no AE of special interest have been defined. | [] |
NCT03595618 | 8.7 | Definition of Events requiring an immediate notification (ERIN) | 8.7. Definition of Events requiring an immediate notification (ERIN) An event must be notified immediately (i.e. without delay and within 24 hours at the latest) to the sponsor if it is: - a serious adverse event, - a pregnancy and other special situations. | [] |
NCT03595618 | 8.8 | Classification of an adverse event (seriousness, severity, causality) | 8.8. Classification of an adverse event (seriousness, severity, causality) It is important that the investigator gives his/her own opinion regarding the seriousness, the severity of the event as well as the causal relationship between an adverse event and the test drug. This evaluation must be assessed by the investiga... | [
"Gr a di n g of A d verse E ve nt S e v erit y"
] |
NCT03595618 | 8.9 | Reporting procedures | 8.9. Reporting procedures | [] |
NCT03595618 | 8.9.1 | Time frame for adverse event reporting | 8.9.1. Time frame for adverse event reporting Any event meeting the above mentioned definitions (see sections 8.3 to 8.7) must be reported to the sponsor on an AE form if it occurred: - before the first intake of the study drug, for event associated with any procedure/condition required by the study protocol: procedure... | [] |
NCT03595618 | 8.9.2 | Responsibilities of the investigator | 8.9.2. Responsibilities of the investigator For any adverse event and special situation mentioned above the investigator must: - Note in the patient's medical file the date on which he/she learned of the event (at a follow-up visit or a telephone contact with the patient or a third person, …) and any other relevant inf... | [] |
NCT03595618 | 8.9.2.1 | Documentation of the event | 8.9.2.1. Documentation of the event The investigator must ensure that all events are well documented. In particular for ERIN, he/she should provide the sponsor, as they become available, with anonymized copies of the documents which provide additional useful information, such as hospital admission reports, reports of f... | [] |
NCT03595618 | 8.9.2.2 | Follow-up of adverse events | 8.9.2.2. Follow-up of adverse events The investigator must ensure that follow-up of the patient is appropriate to the nature of the event, and that it continues until resolution if deemed necessary. Any change in terms of diagnosis, severity, seriousness, measures taken, causality or outcome regarding an adverse event ... | [] |
NCT03595618 | 8.9.2.3 | Recording Methods in the e-CRF | 8.9.2.3. Recording Methods in the e-CRF Adverse events must be documented on the AE page of the e-CRF. In case of chronic disease: - if the disease is known when the patient enters in the study, only worsening (increased frequency and/or intensity of the episodes/attacks) will be documented as an adverse event, - if th... | [] |
NCT03595618 | 8.9.2.4 | Procedure for an event requiring an immediate notification (ERIN) | 8.9.2.4. Procedure for an event requiring an immediate notification (ERIN) Any ERIN (SAE, pregnancy and other special situation) must be reported within 24h of knowledge. | [] |
NCT03595618 | 8.9.2.4.1 | Serious Adverse Event | 8.9.2.4.1. Serious Adverse Event In case of Serious Adverse Event (SAE), the investigator must: - Immediately after being informed of this event, fill in the patient's medical file as well as the «Adverse Event» page of the e-CRF according to the general instructions available in the e-CRF, without waiting for the resu... | [] |
NCT03595618 | 8.9.2.4.2 | Special situations | 8.9.2.4.2. Special situations - In case of a special situation not associated with an AE (except pregnancy), the investigator should report it on a "special situation not associated with an adverse event" page of the e-CRF. - In case of a special situation associated with an AE, the investigator should report it on an ... | [] |
NCT03595618 | 8.9.2.4.3 | Pregnancy | 8.9.2.4.3. Pregnancy If pregnancy concerns a patient or a partner of a patient, the investigator immediately after being informed of this event must fill in the paper-based "Pregnancy Report form" and send it within 24 h of knowledge by fax (or e-mail) to the person(s) designated in the contact details provided in the ... | [] |
NCT03595618 | 8.9.3 | Responsibilities of the sponsor | 8.9.3. Responsibilities of the sponsor In accordance with international guidelines, the assessment of the seriousness and the causality of AE are usually made by the investigator but falls also under sponsor's duties. The causality and the seriousness may be upgraded (but never downgraded) by the sponsor. If the assess... | [] |
NCT03595618 | 8.10 | Responsibilities of data safety monitoring board | 8.10. Responsibilities of data safety monitoring board In accordance with the DSMB charter and the rules for DSMB functioning (refer to section 12.4 of the clinical study protocol), the DSMB is responsible for reviewing the safety data on a regular basis, and providing written recommendations to the Sponsor regarding t... | [] |
NCT03595618 | 9 | OTHER ASSESSMENTS NOT SPECIFICALLY RELATED TO EFFICACY OR SAFETY | 9. OTHER ASSESSMENTS NOT SPECIFICALLY RELATED TO EFFICACY OR SAFETY | [] |
NCT03595618 | 9.1 | Pharmacokinetics | 9.1. Pharmacokinetics S201086/GLPG1972 concentration (and metabolite[s] if applicable) will be analyzed. Plasma analyses for S201086/GLPG1972 will be performed by the assay centre using a validated analytical method. For all patients, blood samples (5 mL/time-point) will be collected in W004, W012, W028, 'W040, W052 an... | [] |
NCT03595618 | 9.3 | Assessment related to exclusion criteria | 9.3. Assessment related to exclusion criteria The following assessments will be performed on screening samples: biological laboratory examinations with Hepatitis B and C, and HIV. | [] |
NCT03595618 | 10 | STATISTICS | 10. STATISTICS | [] |
NCT03595618 | 10.1 | Statistical analysis | 10.1. Statistical analysis The Statistical Analysis Plan and associated templates for Tables, Listings and Graphs, will be written just after finalizing the protocol and definitively completed before breaking the blind of the study These specifications will detail the implementation of all the planned statistical analy... | [] |
NCT03595618 | 10.1.1 | Endpoints | 10.1.1. Endpoints | [] |
NCT03595618 | 10.1.1.1 | Efficacy endpoints | 10.1.1.1. Efficacy endpoints | [] |
NCT03595618 | 10.1.1.1.1 | Primary efficacy endpoint | 10.1.1.1.1. Primary efficacy endpoint The primary efficacy endpoint is the change from baseline to W052 in cartilage thickness in the cMTFC assessed by qMRI on the target knee (centralized reading). | [] |
NCT03595618 | 10.1.1.1.2 | Secondary efficacy endpoints | 10.1.1.1.2. Secondary efficacy endpoints The secondary efficacy endpoints are: - The proportion of "Structural progressors" at W052. A "structural progressors" is defined as a patient who had an 8% cartilage loss in cMTFC between baseline and W052. - The change from baseline to W052 in WOMAC total score and subscales s... | [] |
NCT03595618 | 10.1.1.2 | Safety endpoints | 10.1.1.2. Safety endpoints The safety endpoints are: - For AEs: - The number of AEs, the number and percentage of patients reporting at least one AE. The AE are: - Serious adverse events (SAE) during the study, according to the investigator or sponsor opinion. - Emergent adverse event (EAE) under treatment. The definit... | [] |
NCT03595618 | 10.1.1.4 | Other endpoints | 10.1.1.4. Other endpoints Not applicable. | [] |
NCT03595618 | 10.1.1.5 | Pharmacokinetics endpoints | 10.1.1.5. Pharmacokinetics endpoints Plasma concentrations of S201086/GLPG1972 (and those of metabolite[s] if applicable) will be documented with descriptive statistics (mean, median, standard deviation, minimum and maximum) at each time-point and each dose for trough plasma concentration (Crougn) values. \$201086/GLPG... | [] |
NCT03595618 | 10.1.2 | Analysis sets and subgroups / Treatment groups | 10.1.2. Analysis sets and subgroups / Treatment groups | [] |
NCT03595618 | 10.1.2.1 | Analysis sets and subgroups | 10.1.2.1. Analysis sets and subgroups
- Modified Randomised Set (mRS): The modified Randomised Set (mRS) will be constituted of all included patients to whom a therapeutic unit was randomly assigned using IWRS. The mRS will be used for efficacy analyses. Patients will be analysed according to the randomised treatment.... | [
"- Modified Randomised Set (mRS):",
"- Safety Set (SS):"
] |
NCT03595618 | 10.1.2.2 | Treatment groups | 10.1.2.2. Treatment groups Treatment groups considered will be S201086/GLPG1972 75 mg, S201086/GLPG1972 150 mg, S201086/GLPG1972 300 mg and placebo. | [] |
NCT03595618 | 10.1.3 | Statistical methods | 10.1.3. Statistical methods | [] |
NCT03595618 | 10.1.3.1 | General considerations | 10.1.3.1. General considerations | [] |
NCT03595618 | 10.1.3.1.1 | Multiplicity issues | 10.1.3.1.1. Multiplicity issues In order to take into account the multiplicity of comparisons associated with the primary objective of the study (demonstration of superiority of at least one S201086/GLPG1972 dose as compared to placebo on the primary efficacy endpoint); a Dunnett's procedure will be used for the primar... | [] |
NCT03595618 | 10.1.3.1.2 | Handling of missing data | 10.1.3.1.2. Handling of missing data For the primary analysis, a mixed-effects model for repeated measures approach will be used. In this model, two post-baseline time-points will be considered: W028 and W052. From one patient to another, possible distinct situations of remaining missing data have been identified, just... | [] |
NCT03595618 | 10.1.3.1.3 | Statistical elements | 10.1.3.1.3. Statistical elements | [] |
NCT03595618 | 10.1.3.1.3.1 | Descriptive statistics | 10.1.3.1.3.1. Descriptive statistics The following descriptive statistics will be provided depending on the nature of considered data: - Discrete data: number of observed values, number and percentage of patients per class. - Continuous data: number of observed values, mean and standard deviation, median, first and thi... | [] |
NCT03595618 | 10.1.3.1.3.2 | Estimations and statistical tests | 10.1.3.1.3.2. Estimations and statistical tests The type I error of the statistical tests will be set at 5% (two-sided situation), which is consistent with the objective of demonstrating the superiority of S201086/GLPG1972 versus placebo (one-sided situation at 2.5%). The treatment effect will be estimated as well as i... | [] |
NCT03595618 | 10.1.3.2 | Study patients: Disposition, baseline characteristics and follow-up | 10.1.3.2. Study patients: Disposition, baseline characteristics and follow-up Demographic data and other baseline characteristics such as prognostic factors and baseline value of endpoints will be described by treatment group, to assess their comparability, by treatment group and with the overall in the mRS. Dispositio... | [] |
NCT03595618 | 10.1.3.3 | Efficacy analysis | 10.1.3.3. Efficacy analysis | [] |
NCT03595618 | 10.1.3.3.1 | Primary efficacy endpoint | 10.1.3.3.1. Primary efficacy endpoint | [] |
NCT03595618 | 10.1.3.3.1.1 | Primary analysis | 10.1.3.3.1.1. Primary analysis
Main analysis strategy: In order to meet the primary objective of the study, the efficacy of at least one dose of S201086/GLPG1972 as compared to placebo after 52 weeks of treatment in reducing cartilage loss in patients with knee OA will be assessed from the change from baseline to W052... | [
"Main analysis strategy:",
"Sensitivity analyses:"
] |
NCT03595618 | 10.1.3.3.1.2 | Secondary analyses | 10.1.3.3.1.2. Secondary analyses For each treatment group, descriptive statistics will be provided for the primary endpoint (in terms of value at each visit and change from baseline to each post-baseline visit), overall and by regions. | [] |
NCT03595618 | 10.1.3.3.2 | Secondary efficacy endpoints | 10.1.3.3.2. Secondary efficacy endpoints For the proportion of "structural progressors" and proportion of OMERACT-OARSI responders at W052, the difference between each S201086/GLPG1972 dose and placebo will be studied in patients of the mRS, considering a multiple imputation for handling all missing data and using a lo... | [] |
NCT03595618 | 10.1.3.4 | Safety analysis | 10.1.3.4. Safety analysis | [] |
NCT03595618 | 10.1.3.4.1 | Adverse events | 10.1.3.4.1. Adverse events Number of events, number and percentage of patients reporting at least one event, presented by system organ class and preferred term (depending on the analysis), will be provided for SAEs and EAEs over the study. EAEs will be described according to the seriousness, the intensity, the relation... | [] |
NCT03595618 | 10.1.3.4.2 | Clinical laboratory evaluation | 10.1.3.4.2. Clinical laboratory evaluation The following analyses will be performed, depending on the nature of considered endpoints (i.e., quantitative or qualitative): - Descriptive statistics on value at baseline, on value at each post-baseline visit under treatment, on last post-baseline value under treatment and, ... | [] |
NCT03595618 | 10.1.3.4.3 | Vital signs, clinical examination and other observations related to safety | 10.1.3.4.3. Vital signs, clinical examination and other observations related to safety | [] |
NCT03595618 | 10.1.3.4.3.1 | Vital signs and clinical examination | 10.1.3.4.3.1. Vital signs and clinical examination Blood pressure, pulse rate, body weight and BMI will be described, in terms of value at baseline, value at each post-baseline visit under treatment and last post-baseline value under treatment; as well as in terms of change from baseline to each post baseline visit und... | [] |
NCT03595618 | 10.1.3.4.3.2 | Electrocardiogram | 10.1.3.4.3.2. Electrocardiogram ECG parameters will be described, in terms of value at baseline, value at each post-baseline visit under treatment and last post-baseline value under treatment; as well as, for quantitative endpoints, in terms of change from baseline to each post baseline visit under treatment and to las... | [] |
NCT03595618 | 10.1.3.4.3.3 | Special situations not associated with an AE | 10.1.3.4.3.3. Special situations not associated with an AE Special situations not associated with an AEs will be described in the mRS. | [] |
NCT03595618 | 10.1.3.5 | Exploratory analysis | 10.1.3.5. Exploratory analysis  | [] |
NCT03595618 | 10.1.4 | Interim analysis | 10.1.4. Interim analysis Not applicable | [] |
NCT03595618 | 10.2 | Determination of sample size | 10.2. Determination of sample size The determination of the sample size was performed considering the change from baseline to 'WO052 in cartilage thickness in the cMTFC, expressed in mm and measured by gqMRL The objective is to demonstrate that at least one S201086/GLPG1972 dose is superior to placebo in the mRS, based... | [] |
NCT03595618 | 11 | DIRECT ACCESS TO SOURCE DATA / DOCUMENTS | 11. DIRECT ACCESS TO SOURCE DATA / DOCUMENTS The investigator will allow the monitors, the persons responsible for the audit, the representatives of the IRB/IEC, and of the Regulatory Agencies to have direct access to source data / documents. | [] |
NCT03595618 | 12 | QUALITY CONTROL AND QUALITY ASSURANCE | 12. QUALITY CONTROL AND QUALITY ASSURANCE | [] |
NCT03595618 | 12.1 | Study monitoring | 12.1. Study monitoring Clinical site monitoring is conducted to ensure that the rights and well-being of human patients are protected, that the reported trial data are accurate, complete, and verifiable, and that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and ... | [] |
NCT03595618 | 12.1.1 | Before the study | 12.1.1. Before the study The investigator will allow the monitor to visit the site and facilities where the study will take place in order to ensure compliance with the applicable protocol requirements. Training sessions may be organized for the investigators and/or instruction manuals may be given to the investigators... | [] |
NCT03595618 | 12.1.2 | During the study | 12.1.2. During the study The investigator will allow the monitor to: - review of the study site's processes and procedures, - verify appropriate clinical investigator supervision of study site staff and third party vendors, - inspect the site, the facilities and the material used for the study, - meet all members of hi... | [] |
NCT03595618 | 12.2 | Computerized medical file | 12.2. Computerized medical file If computerized medical files are used the following requirements apply. The computerized medical file must: - Be validated to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records - Have the ability to generate accurate and ... | [] |
NCT03595618 | 12.3 | Audit - Inspection | 12.3. Audit - Inspection The investigator should be informed that an audit may be carried out during or after the end of the study. The investigator should be informed that the Regulatory Agencies may also carry out an inspection in the facilities of the sponsor and/or the study centers. The sponsor will inform the inv... | [] |
NCT03595618 | 12.4 | Supervisory committees | 12.4. Supervisory committees DSMB recommendations will be forwarded to the IRB/IEC/ Regulatory Agencies only if relevant for the safety of patients. According to the "Guideline on data monitoring committees" (Guideline CHMP/EWP/5872/03 Corr., 27 July 2005) and "Establishment and Operation of Clinical Trial Data Monitor... | [] |
NCT03595618 | 13 | ETHICS | 13. ETHICS | [] |
NCT03595618 | 13.1 | Institutional Review Board(s)/Independent Ethics Committee(s) | 13.1. Institutional Review Board(s)/Independent Ethics Committee(s) The study protocol, the "Patient information and consent form" document, the list of investigators document, the insurance documents, the Investigator's Brochure of administered IMPs will be submitted to (an) IRB(s)/IEC(s) by the investigator(s) or the... | [] |
NCT03595618 | 13.2 | Study conduct | 13.2. Study conduct The study will be performed in accordance with the ethical principles stated in the Declaration of Helsinki 1964 (see Appendix 1) with the GCP and with the applicable regulatory requirements. | [] |
NCT03595618 | 13.3 | Patient information and informed consent | 13.3. Patient information and informed consent In any case, the patient (and/or his/her legal representative, when required) must be informed that he/she is entitled to be informed about the outcome of the study by the investigator. The investigator (or designee) is to collect written consent from each patient before h... | [] |
NCT03595618 | 13.4 | Modification of the information and consent form | 13.4. Modification of the information and consent form Any change to the information and consent form constitutes an amendment to this document and must be submitted for approval to the IRB/IEC(s), and if applicable to the Regulatory Agencies. A copy of the new version of the information and consent form in the languag... | [] |
NCT03595618 | 14 | DATA HANDLING AND RECORD KEEPING | 14. DATA HANDLING AND RECORD KEEPING | [] |
NCT03595618 | 14.1 | Source data | 14.1. Source data Source data and source documents of the center should be clearly identified in a specific, detailed and signed document before the beginning of the study. The following documents are considered as source documents: - Notes in the medical file (including nurse files) - Therapeutic Unit Tracking Form (T... | [] |
NCT03595618 | 14.2 | Study data | 14.2. Study data A 21 CFR Part 11-compliant electronic data capture system is going to be used for this study. An electronic case report form (eCRF) is designed to record the data required by the protocol and collected by the investigator. The e-CRF will be produced by I.R.I.S. in compliance with its specifications. Th... | [] |
NCT03595618 | 14.3 | Data management | 14.3. Data management Data are collected via an eCRF and stored in a secured database. For data collected on the e-CRF, the Data & Clinical Logistics of I.R.I.S. is responsible for data processing, including data validation according to a specification manual describing the checks to be carried out. As a result of data... | [] |
NCT03595618 | 14.4 | Archiving | 14.4. Archiving The investigator will keep all information relevant to the study for at least 25 years after the end of the study, or more if specified by the local regulation, or for US sites two years after approval of the New Drug Application (NDA) or discontinuation of the Investigational New Drug (IND) (it include... | [] |
NCT03595618 | 15 | INSURANCE | 15. INSURANCE | [] |
NCT03595618 | 15.1 | For non US countries: | 15.1. For non US countries: I.R.I.S., or any parent company of SERVIER GROUP in charge of the management of clinical trials, is insured under the liability insurance program subscribed by LES LABORATOIRES SERVIER to cover its liability as sponsor of clinical trials on a worldwide basis. Where an indemnification system ... | [] |
NCT03595618 | 15.2 | For US country only: | 15.2. For US country only: | [] |
NCT03595618 | 15.2.1 | Indemnification | 15.2.1. Indemnification Under the conditions of a contract concluded between investigator, site and the sponsor Galapagos NV or designee, which shall prevail, the sponsor Galapagos NV shall, except in case of gross negligence or willful misconduct, indemnify and hold harmless the investigator and his/her medical staff ... | [] |
NCT03595618 | 15.2.2 | Insurance | 15.2.2. Insurance The sponsor Galapagos NV shall maintain insurance coverage that is sufficient to cover its obligations and that is consistent with human clinical study local regulations. Save in case of gross negligence or willful misconduct of the investigator, and provided that the patient has been treated accordin... | [] |
NCT03595618 | 16 | OWNERSHIP OF THE RESULTS – DATA SHARING POLICY AND PUBLICATION POLICY | 16. OWNERSHIP OF THE RESULTS – DATA SHARING POLICY AND PUBLICATION POLICY Les Laboratoires Servier and Institut de Recherches Servier and Galapagos ("Servier"), and I.R.I.S. affiliate, and Galapagos N.V. ("Galapagos") entered into a Product Development, Option, License and Commercialization Agreement dated as of 28 Jun... | [] |
NCT03595618 | 17 | ADMINISTRATIVE CLAUSES | 17. ADMINISTRATIVE CLAUSES | [] |
NCT03595618 | 17.1 | Concerning the sponsor and the investigator | 17.1. Concerning the sponsor and the investigator | [] |
NCT03595618 | 17.1.1 | Persons to inform | 17.1.1. Persons to inform In accordance with local regulations, the investigator and/or the sponsor will inform the Director of the medical institution, the pharmacist involved in the study and the Director of the analysis laboratory. With the agreement of the patient, the investigator will inform the patient's general... | [] |
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