protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT03224325 | 7.4.1 | Diet and Fluid | 7.4.1 Diet and Fluid Subjects in each cohort will be confined during dosing and be kept in the study unit for 24 hours after the last dose for non-CSF cohorts and 48 hours after catheter removal in CSF cohorts. The total confinement period in non-CSF cohorts will be 19 days (Day -2 to Day 17), 20 days in CSF cohorts wh... | [] |
NCT03224325 | 7.4.2 | Activity | 7.4.2 Activity Subjects will remain upright (seated, standing, or ambulatory) for 4 hours following the dose administration, except as necessitated by the occurrence of an AE or study procedures (eg, obtaining 12-lead ECG). Subjects will refrain from strenuous and/or unaccustomed exercise throughout the entire course o... | [] |
NCT03224325 | 7.5 | Criteria for Discontinuation or Withdrawal of a Subject | 7.5 Criteria for Discontinuation or Withdrawal of a Subject The primary reason for discontinuation or withdrawal of the subject from the study or study medication should be recorded in the electronic case report form (eCRF) using the following categories. - 1. AE. The subject has experienced an AE that requires early t... | [] |
NCT03224325 | 7.6 | Procedures for Discontinuation or Withdrawal of a Subject | 7.6 Procedures for Discontinuation or Withdrawal of a Subject The investigator may discontinue a subject's study participation at any time during the study when the subject meets the study termination criteria described in Section [6.5.5.](#page-26-0) In addition, a subject may discontinue his or her participation with... | [] |
NCT03224325 | 7.7 | Subject Replacement | 7.7 Subject Replacement Subjects may be replaced on a case-by-case basis at the discretion of the sponsor. | [] |
NCT03224325 | 8.0 | CLINICAL STUDY MATERIAL MANAGEMENT | 8.0 CLINICAL STUDY MATERIAL MANAGEMENT | [] |
NCT03224325 | 8.1 | Clinical Study Drug | 8.1 Clinical Study Drug Details regarding the active drug and placebo in tablet dosage form and the extemporaneous preparation can be found in the IB and compounding manual respectively. Clinical study drug will be packaged to support enrollment and replacement subjects as required. When a replacement subject is requir... | [] |
NCT03224325 | 8.1.1 | Clinical Study Drug Labeling | 8.1.1 Clinical Study Drug Labeling Clinical study drug will be affixed with a clinical label in accordance with regulatory requirements. | [] |
NCT03224325 | 8.1.2 | Clinical Study Drug Inventory and Storage | 8.1.2 Clinical Study Drug Inventory and Storage Clinical study drug must be stored in a secure, limited-access location and remained in the original container until dispensed. The storage condition and temperature excursion information can be found in the compounding manual. Receipt and dispensing of study drug must be... | [] |
NCT03224325 | 8.1.3 | Clinical Study Drug Blinding | 8.1.3 Clinical Study Drug Blinding This is an investigator and subject blinded, sponsor-open study. The investigator and subjects are blinded to treatment assignment. The unblinded study drug supply will be provided to an unblinded pharmacist or other qualified trial site personnel who will blind the trial supplies. Tr... | [] |
NCT03224325 | 8.1.4 | Randomization Code Creation and Storage | 8.1.4 Randomization Code Creation and Storage Randomization personnel of the sponsor or designee will generate the randomization schedule. All randomization information will be stored in a secured area, accessible only by authorized personnel. | [] |
NCT03224325 | 8.1.5 | Clinical Trial Blind Maintenance/Unblinding Procedure | 8.1.5 Clinical Trial Blind Maintenance/Unblinding Procedure The investigational drug blind is maintained through a randomization schedule held by the randomization personnel. The investigational drug blind shall not be broken by the investigator unless information concerning the investigational drug is necessary for th... | [] |
NCT03224325 | 8.1.6 | Accountability and Destruction of Sponsor-Supplied Drugs | 8.1.6 Accountability and Destruction of Sponsor-Supplied Drugs The investigator is responsible for keeping accurate records of the clinical study drug received from the sponsor or designee, the amount dispensed to and returned by the subjects and the amount remaining at the conclusion of the study. For the study site, ... | [] |
NCT03224325 | 9.0 | STUDY PROCEDURES | 9.0 STUDY PROCEDURES The following sections describe the study procedures and data to be collected as indicated in the Schedule of Study Procedures (Section [3.0\)](#page-11-0). For each procedure, subjects are to be assessed by the same investigator or site personnel whenever possible. Please note that it may become n... | [] |
NCT03224325 | 9.1 | Administrative Procedures | 9.1 Administrative Procedures | [] |
NCT03224325 | 9.1.1 | Informed Consent Procedure | 9.1.1 Informed Consent Procedure Informed consent must be obtained before the subject entering into the study and before any protocol-directed procedures are performed, including requesting that a subject fast for laboratory evaluations. PGx informed consent is a component of the overall study informed consent. The req... | [] |
NCT03224325 | 9.1.1.1 | Assignment of Screening and Randomization Numbers | 9.1.1.1 Assignment of Screening and Randomization Numbers All consented subjects will be given a unique screening number that will be used to identify the subject for all procedures that occur before randomization or allocation. Each subject will be assigned only 1 screening number. Screening numbers must not be re-use... | [] |
NCT03224325 | 9.1.1.2 | Study Drug Assignment | 9.1.1.2 Study Drug Assignment On Day 1, subjects will be assigned a randomization number in ascending numerical order at the study site. The randomization number encodes the subject assignment to either the TAK-831 or the placebo arm of the study, according to the randomization schedule generated before the study by th... | [] |
NCT03224325 | 9.1.2 | Inclusion and Exclusion | 9.1.2 Inclusion and Exclusion Each subject is assessed through randomization, according to the eligibility criteria provided in Section [7.0.](#page-28-2) | [] |
NCT03224325 | 9.1.3 | Medical History/Demography | 9.1.3 Medical History/Demography Qualified site personnel are to collect subject significant medical history and concurrent medical condition per the site's standard of care and appropriate clinical judgment as well as subject demographics. | [] |
NCT03224325 | 9.1.4 | Medication History/Concomitant Medications | 9.1.4 Medication History/Concomitant Medications Medications are defined as prescription and over-the-counter drugs, vitamin supplements, nutraceuticals, and oral herbal preparations. Qualified site personnel are to review subject medication use. | [] |
NCT03224325 | 9.2 | Clinical Procedures and Assessments | 9.2 Clinical Procedures and Assessments | [] |
NCT03224325 | 9.2.1 | Full Physical Examination | 9.2.1 Full Physical Examination Qualified site personnel will conduct full physical examinations. A comprehensive clinical neurological assessment (with a focus on cerebellar signs), will be performed on all subjects (except on CSF collection days in CSF cohorts) as indicated in the Section [3.0](#page-11-0) Schedule o... | [] |
NCT03224325 | 9.2.2 | Height and Weight | 9.2.2 Height and Weight Body weight and height will be obtained with the subject's shoes off, and jacket or coat removed. | [] |
NCT03224325 | 9.2.3 | BMI | 9.2.3 BMI BMI equals a person's weight in kilograms divided by height in meters squared (BMI=kg/m2 ). Body weight and height will be obtained with the subject's shoes off and jacket or coat removed. BMI will be rounded to the nearest whole number according to the standard convention of 0.1 to 0.4 round down and 0.5 to ... | [] |
NCT03224325 | 9.2.4 | Vital Signs | 9.2.4 Vital Signs Body temperature will be measured with an oral (temperature taken at floor of the mouth) or tympanic thermometer. The same method (eg, oral or tympanic) must be used for all subsequent measurements for each individual subject and should be the same for all subjects. Subjects should rest in a supine po... | [] |
NCT03224325 | 9.2.5 | ECGs | 9.2.5 ECGs Special care must be taken for proper lead placement by qualified personnel. Skin should be clean and dry before lead placement. Subjects may need to be shaved to ensure proper lead placement. Female subjects may need to remove their bra. Subjects should be resting in a supine position for at least 5 minutes... | [] |
NCT03224325 | 9.2.5.1 | Safety ECG | 9.2.5.1 Safety ECG Standard 12-lead ECG (singlet) will be recorded. When an ECG is scheduled at the same time as blood draws, or vital signs then the ECG will take priority followed by vital signs and then the blood draw. Vitals will be collected within approximately 0.5 hour before the scheduled timepoint. The blood d... | [] |
NCT03224325 | 9.2.6 | C-SSRS | 9.2.6 C-SSRS Suicidality will be assessed by the use of the C-SSRS [\[10,](#page-69-8)[11\]](#page-69-7). The C-SSRS was developed by researchers at Columbia University as a tool to help systematically assess suicidal ideation and behavior in subjects during participation in a clinical trial of centrally-acting drugs. ... | [] |
NCT03224325 | 9.2.7 | Study Drug Administration | 9.2.7 Study Drug Administration This is an investigator and subject blinded study; therefore, TAK-831 or matching placebo will be administered orally on Day 1 and Days 3 through 16 in a blinded fashion. | [] |
NCT03224325 | 9.2.7.1 | Monitoring Subject Treatment Compliance | 9.2.7.1 Monitoring Subject Treatment Compliance Study medication will be administered while subjects are under observation in the clinical research unit. Following administration of the study medication, appropriate mouth and/or hand checks will be performed to ensure that the dose is swallowed and noted in the source ... | [] |
NCT03224325 | 9.2.8 | AE Monitoring | 9.2.8 AE Monitoring AE monitoring begins following signing of informed consent. Changes in subject health status from baseline assessment to trial drug administration should be captured in the subject's medical history. A complete description of AE collections and procedures is provided in Section [10.0.](#page-47-1) | [] |
NCT03224325 | 9.2.9 | Laboratory Procedures and Assessments | 9.2.9 Laboratory Procedures and Assessments Laboratory samples will be collected in accordance with acceptable laboratory procedures. Samples will be taken on the days stipulated in the Schedule of Study Procedures (Section [3.0\)](#page-11-0). | [] |
NCT03224325 | 9.2.9.1 | Clinical Laboratory Tests | 9.2.9.1 Clinical Laboratory Tests
Hematology Hematology will consist of the following tests: | Erythrocytes (red blood cells) | Hemoglobin | |-----------------------------------------------------------|-------------------------------------------------------------| | Hematocrit | Platelets | | Leukocytes (white blood c... | [
"Hematology",
"Urinalysis",
"Chemistry"
] |
NCT03224325 | 9.2.9.2 | Diagnostic Screening | 9.2.9.2 Diagnostic Screening
Serum/Blood Serum diagnostic evaluations will include the following tests: | Alcohol | Hepatitis Screen (HBsAg, HCV antibody) | | |----------------------------|----------------------------------------|--| | hCG (female subjects only) | HIV | | | | FSH (female subjects only) | |
Urine A ur... | [
"Serum/Blood",
"Urine"
] |
NCT03224325 | 9.3.1 | PK Measurements | 9.3.1 PK Measurements The PK parameters of TAK-831 will be derived using noncompartmental analysis methods and will be determined from the concentration-time data for all evaluable subjects. Actual sampling times, rather than scheduled sampling times, will be used in all PK computations involving sampling times for pla... | [] |
NCT03224325 | 9.3.1.1 | PK Sample Collection | 9.3.1.1 PK Sample Collection PK blood and CSF samples for TAK-831 concentrations will be collected as specified in the Schedule of Trial Procedures (See Section [3.0\)](#page-11-0). The actual date and time of each PK (blood and CSF) sample collection as well as the date and time of study drug dosing for the most recen... | [] |
NCT03224325 | 9.3.1.2 | PK Sample Analysis | 9.3.1.2 PK Sample Analysis Plasma and CSF concentrations of TAK-831 will be measured by a validated HPLC with tandem mass spectrometry assay. Part of the archival plasma and CSF samples will be used for potential analysis of unknown metabolite characterization, if appropriate. | [] |
NCT03224325 | 9.3.2 | PD Measurements | 9.3.2 PD Measurements  | [] |
NCT03224325 | 9.3.2.1 | PD Sample Collection | 9.3.2.1 PD Sample Collection
Blood The actual time of sample collection, time since last dose was administered, and time since last meal will be recorded on the source document and eCRF. Instructions for sample processing and shipment are provided in the laboratory manual.  ![](page45Figure4.jp... | [
"Blood"
] |
NCT03224325 | 9.3.3 | PGx Measurements | 9.3.3 PGx Measurements The sampling of whole blood for PGx and genotyping analysis is mandatory; every subject must sign informed consent in order to participate in this study. DNA samples will be used to evaluate drug metabolic enzyme and transporter polymorphisms. Also, since PGx is an evolving science, many genes an... | [] |
NCT03224325 | 9.3.4 | Total Blood Volume | 9.3.4 Total Blood Volume Approximately 380 mL of total blood volume will be collected. | [] |
NCT03224325 | 9.3.5 | Confinement | 9.3.5 Confinement Subjects in each cohort will be confined during dosing and be kept in the study unit for 24 hours after the last dose for non-CSF cohorts and 48 hours after catheter removal in CSF cohorts. The total confinement period in non-CSF cohorts will be 19 days (Day -2 to Day 17), 20 days in CSF cohorts where... | [] |
NCT03224325 | 10.0 | ADVERSE EVENTS | 10.0 ADVERSE EVENTS | [] |
NCT03224325 | 10.1 | Definitions and Elements of AEs | 10.1 Definitions and Elements of AEs An AE is defined as any untoward medical occurrence in a clinical investigation subject who has signed informed consent to participate in a study; it does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sig... | [
"Pre-existing conditions:",
"Worsening of AEs:",
"Changes in severity of AEs:",
"Preplanned surgeries or procedures:",
"Elective surgeries or procedures:",
"Overdose:",
"CONFIDENTIAL"
] |
NCT03224325 | 10.1.1 | SAEs | 10.1.1 SAEs An SAE is defined as any untoward medical occurrence that at any dose: - 1. Results in DEATH. - 2. Is LIFE THREATENING. - The term "life threatening" refers to an event in which the subject was at risk of death at the time of the event; it does not refer to an event that hypothetically might have caused dea... | [] |
NCT03224325 | 10.1.2 | Special Interest AEs | 10.1.2 Special Interest AEs No AEs of special interest have been identified for TAK-831. | [] |
NCT03224325 | 10.2 | AE Procedures | 10.2 AE Procedures | [] |
NCT03224325 | 10.2.1 | Assigning Severity/Intensity of AEs | 10.2.1 Assigning Severity/Intensity of AEs The different categories of severity/intensity are: Mild: An AE that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. Moderate: An AE that is usually alleviate... | [] |
NCT03224325 | 10.2.2 | Assigning Causality of AEs | 10.2.2 Assigning Causality of AEs The relationship of each AE to study medication(s) will be assessed using the following categories: Related: An AE that follows a reasonable temporal sequence from administration of a drug (including the course after withdrawal of the drug), or for which a causal relationship is at lea... | [] |
NCT03224325 | 10.2.3 | Start Date | 10.2.3 Start Date The start date of the AE is the date that the first signs/symptoms were noted by the subject and/or investigator. | [] |
NCT03224325 | 10.2.4 | End Date | 10.2.4 End Date The end date of the AE is the date at which the subject recovered, the event resolved but with sequelae or the subject died. | [] |
NCT03224325 | 10.2.5 | Pattern of AE (Frequency) | 10.2.5 Pattern of AE (Frequency) Episodic AEs (eg, headache) or those which occur repeatedly over a period of consecutive days are intermittent. All other events are continuous. | [] |
NCT03224325 | 10.2.6 | Action Taken With Study Treatment | 10.2.6 Action Taken With Study Treatment - Drug withdrawn: a study medication is stopped because of the particular AE. - Dose not changed: the particular AE did not require stopping a study medication. - Unknown: only to be used if it has not been possible to determine what action has been taken. - Not applicable: a st... | [] |
NCT03224325 | 10.2.7 | Outcome | 10.2.7 Outcome - Recovered/resolved: subject returned to first assessment status with respect to the AE. - Recovering/resolving: the intensity is lowered by one or more stages: the diagnosis has or signs/symptoms have almost disappeared; the abnormal laboratory value improved, but has not returned to the normal range o... | [] |
NCT03224325 | 10.2.8 | Collection and Reporting of AEs, SAEs, Special Interest AEs, and Abnormal LFTs | 10.2.8 Collection and Reporting of AEs, SAEs, Special Interest AEs, and Abnormal LFTs | [] |
NCT03224325 | 10.2.8.1 | Collection Period | 10.2.8.1 Collection Period Collection of AEs (ie, AEs, SAEs, Special Interest AEs, and Abnormal LFTs) will commence at the time the subject signs the informed consent. Routine collection of AEs will continue until the follow-up phone call on Day 30 (±2 days), approximately 15 days after the last dose of investigational... | [] |
NCT03224325 | 10.2.8.2 | Reporting AEs | 10.2.8.2 Reporting AEs At each study visit, the investigator will assess whether any subjective AEs have occurred. A neutral question, such as "How have you been feeling since your last visit?" may be asked. Subjects may report AEs occurring at any other time during the study. Subjects experiencing an SAE before the fi... | [] |
NCT03224325 | 10.2.8.3 | Reporting SAEs | 10.2.8.3 Reporting SAEs When an SAE occurs through the AE collection period it should be reported according to the procedure outlined below: A Takeda SAE form must be completed, in English and signed by the investigator immediately or within 24 hours of first onset or notification of the event. The information should b... | [
"SAE Follow-up"
] |
NCT03224325 | 10.2.8.4 | Reporting Special Interest AEs | 10.2.8.4 Reporting Special Interest AEs No AEs of special interest have been identified for TAK-831. | [] |
NCT03224325 | 10.2.8.5 | Reporting of Abnormal LFTs | 10.2.8.5 Reporting of Abnormal LFTs If a subject is noted to have ALT or AST elevated >3×ULN on 2 consecutive occasions, the abnormality should be recorded as an AE. In addition, an LFT Increases eCRF must be completed providing additional information on relevant recent history, risk factors, clinical signs and symptom... | [] |
NCT03224325 | 10.2.9 | Safety Reporting to Investigators, IRBs or IECs, and Regulatory Authorities | 10.2.9 Safety Reporting to Investigators, IRBs or IECs, and Regulatory Authorities The sponsor will be responsible for reporting all suspected unexpected serious adverse reactions (SUSARs) and any other applicable SAEs to regulatory authorities, investigators and IRBs or IECs, as applicable, in accordance with national... | [] |
NCT03224325 | 11.0 | STATISTICAL METHODS | 11.0 STATISTICAL METHODS | [] |
NCT03224325 | 11.1 | Statistical and Analytical Plans | 11.1 Statistical and Analytical Plans A statistical analysis plan will be prepared and finalized before unblinding of treatment assignments. This document will provide further details regarding the definition of analysis variables and analysis methodology to address all study objectives. A blinded targeted data review ... | [] |
NCT03224325 | 11.1.1 | Analysis Sets | 11.1.1 Analysis Sets | [] |
NCT03224325 | 11.1.1.1 | Safety Set | 11.1.1.1 Safety Set The safety set will include all randomized subjects who receive at least 1 dose of study medication. Subjects in this analysis set will be used for demographic, baseline characteristics, and safety summaries. | [] |
NCT03224325 | 11.1.1.2 | PK Set | 11.1.1.2 PK Set The PK set will include all randomized subjects who receive at least one dose of study medication and who have any available plasma concentration data. | [] |
NCT03224325 | 11.1.1.3 | PD Set | 11.1.1.3 PD Set The PD set will consist of all subjects who receive at least 1 dose of study drug and have at least 1 postdose PD result. If any subject is found to be noncompliant with the dosing schedule or has incomplete data, a decision will be made on a case-by-case basis as to whether that subject should be inclu... | [] |
NCT03224325 | 11.1.2 | Analysis of Demography and Other Baseline Characteristics | 11.1.2 Analysis of Demography and Other Baseline Characteristics Demographic and baseline characteristics will be summarized for subjects in the safety set by pooled placebo, each TAK-831 dose level, summary statistics (number of subjects, mean, SD, median, minimum, and maximum) will be presented for continuous variabl... | [] |
NCT03224325 | 11.1.3 | PK Analysis | 11.1.3 PK Analysis Concentrations of TAK-831 in plasma (all cohorts) and CSF (CSF Cohort[s]) will be summarized by dose, drug formulation, and day over each scheduled sampling time using descriptive statistics. Individual plasma concentration data versus time will be presented in a data listing. PK parameters of TAK-83... | [] |
NCT03224325 | 11.1.4 | PD Analysis | 11.1.4 PD Analysis  | [] |
NCT03224325 | 11.1.5 | Safety Analysis | 11.1.5 Safety Analysis The safety set will be used for all summaries of safety parameters. Summaries will be presented by pooled placebo, each TAK-831 dose level, drug formulation, TAK-831 overall, and overall. | [] |
NCT03224325 | 11.1.5.1 | AEs | 11.1.5.1 AEs All AEs will be coded by system organ class (SOC) and preferred term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA). TEAEs with onset occurring within 30 days (onset date – last date of dose +1≤30) after study drug administration will be included in the summary tables. All AEs will be... | [] |
NCT03224325 | 11.1.5.2 | Clinical Laboratory Evaluation | 11.1.5.2 Clinical Laboratory Evaluation Individual results of laboratory tests from hematology, chemistry, and urinalysis that meet Takeda's markedly abnormal criteria will be summarized and provided in the data listings. Baseline, postdose, and change from Baseline to postdose laboratory data will be summarized. All c... | [] |
NCT03224325 | 11.1.5.3 | Vital Signs | 11.1.5.3 Vital Signs Individual results of vital signs that meet Takeda's markedly abnormal criteria will be summarized and provided in the data listings. Baseline, postdose, and changes from Baseline in vital sign measurements will be summarized. All vital sign data will be provided in the data listings. | [] |
NCT03224325 | 11.1.5.4 | ECGs | 11.1.5.4 ECGs Individual results of quantitative ECG parameters from the 12-lead safety ECGs that meet Takeda's markedly abnormal criteria will be summarized and provided in the data listings. Baseline, postdose, and changes from Baseline in quantitative ECG parameters will be summarized. Shift tables will be generated... | [] |
NCT03224325 | 11.1.5.5 | Other Safety Parameters | 11.1.5.5 Other Safety Parameters Physical and neurological examination findings and suicidality assessments (C-SSRS) will be presented in data listings. | [] |
NCT03224325 | 11.2 | Interim Analysis and Criteria for Early Termination | 11.2 Interim Analysis and Criteria for Early Termination No formal interim analysis is planned. As described in Section [6.2,](#page-20-0) specific Takeda personnel listed in associated study documentation may be unblinded to analyze data considered necessary to determine subsequent doses and cohort management decision... | [] |
NCT03224325 | 11.3 | Determination of Sample Size | 11.3 Determination of Sample Size The sample size chosen of 8 subjects for all Cohorts (6 active:2 placebo) is considered to be sufficient for evaluation of safety, tolerability, and PK of each cohort to determine the dose for the next cohort. The sample size was not based on statistical power considerations. | [] |
NCT03224325 | 12.0 | QUALITY CONTROL AND QUALITY ASSURANCE | 12.0 QUALITY CONTROL AND QUALITY ASSURANCE | [] |
NCT03224325 | 12.1 | Study-Site Monitoring Visits | 12.1 Study-Site Monitoring Visits Monitoring visits to the study site will be made periodically during the study to ensure that all aspects of the protocol are followed. Source documents will be reviewed for verification of data recorded on the eCRFs. Source documents are defined as original documents, data, and record... | [] |
NCT03224325 | 12.2 | Protocol Deviations | 12.2 Protocol Deviations The investigator should not deviate from the protocol, except where necessary to eliminate an immediate hazard to trial subjects. Should other unexpected circumstances arise that will require deviation from protocol-specified procedures, the investigator should consult with the sponsor or desig... | [] |
NCT03224325 | 12.3 | Quality Assurance Audits and Regulatory Agency Inspections | 12.3 Quality Assurance Audits and Regulatory Agency Inspections The study site also may be subject to quality assurance audits by the sponsor or designees. In this circumstance, the sponsor-designated auditor will contact the site in advance to arrange an auditing visit. The auditor may ask to visit the facilities wher... | [] |
NCT03224325 | 13.0 | ETHICAL ASPECTS OF THE STUDY | 13.0 ETHICAL ASPECTS OF THE STUDY This study will be conducted with the highest respect for the individual participants (ie, subjects) according to the protocol, the ethical principles that have their origin in the Declaration of Helsinki, and the International Conference on Harmonisation (ICH) Harmonised Tripartite Gu... | [] |
NCT03224325 | 13.1 | IRB and/or IEC Approval | 13.1 IRB and/or IEC Approval IRBs and IECs must be constituted according to the applicable state and federal/local requirements of each participating region. The sponsor or designee will require documentation noting all names and titles of members who make up the respective IRB or IEC. If any member of the IRB or IEC h... | [] |
NCT03224325 | 13.2 | Subject Information, Informed Consent, and Subject Authorization | 13.2 Subject Information, Informed Consent, and Subject Authorization Written consent documents will embody the elements of informed consent as described in the Declaration of Helsinki and the ICH Guidelines for GCP and will be in accordance with all applicable laws and regulations. The informed consent form, subject a... | [] |
NCT03224325 | 13.3 | Subject Confidentiality | 13.3 Subject Confidentiality The sponsor and designees affirm and uphold the principle of the subject's right to protection against invasion of privacy. Throughout this study, a subject's source data will only be linked to the sponsor's clinical study database or documentation via a unique identification number. As per... | [] |
NCT03224325 | 13.4 | Publication, Disclosure, and Clinical Trial Registration Policy | 13.4 Publication, Disclosure, and Clinical Trial Registration Policy | [] |
NCT03224325 | 13.4.1 | Publication and Disclosure | 13.4.1 Publication and Disclosure The investigator is obliged to provide the sponsor with complete test results and all data derived by the investigator from the study. During and after the study, only the sponsor may make study information available to other study investigators or to regulatory agencies, except as req... | [] |
NCT03224325 | 13.4.2 | Clinical Trial Registration | 13.4.2 Clinical Trial Registration In order to ensure that information on clinical trials reaches the public in a timely manner and to comply with applicable laws, regulations and guidance, Takeda will, at a minimum register all interventional clinical trials it sponsors anywhere in the world on ClinicalTrials.gov and/... | [] |
NCT03224325 | 13.4.3 | Clinical Trial Results Disclosure | 13.4.3 Clinical Trial Results Disclosure Takeda will post the results of clinical trials on ClinicalTrials.gov or other publicly accessible websites, as required by Takeda Policy/Standard, applicable laws and/or regulations. | [] |
NCT03224325 | 13.5 | Insurance and Compensation for Injury | 13.5 Insurance and Compensation for Injury Each subject in the study must be insured in accordance with the regulations applicable to the site where the subject is participating. If a local underwriter is required, then the sponsor or sponsor's designee will obtain clinical study insurance against the risk of injury to... | [] |
NCT03224325 | 14.0 | ADMINISTRATIVE AND REFERENCE INFORMATION | 14.0 ADMINISTRATIVE AND REFERENCE INFORMATION | [] |
NCT03224325 | 14.1 | Administrative Information | 14.1 Administrative Information | [] |
NCT03224325 | 14.1.1 | Study Contact Information | 14.1.1 Study Contact Information | Contact Type / Role | Contact | |-----------------------------|---------| | SAE and pregnancy reporting | PPD | | | | | [] |
NCT03224325 | 14.1.2 | INVESTIGATOR AGREEMENT | 14.1.2 INVESTIGATOR AGREEMENT I confirm that I have read and that I understand this protocol, the Investigator's Brochure, package insert and any other product information provided by the sponsor. I agree to conduct this study in accordance with the requirements of this protocol and also to protect the rights, safety, ... | [] |
NCT03224325 | 14.1.3 | Study-Related Responsibilities | 14.1.3 Study-Related Responsibilities The sponsor will perform all study-related activities with the exception of those identified in the Study-Related Responsibilities template. The vendors identified for specific study-related activities will perform these activities in full or in partnership with the sponsor. | [] |
NCT03224325 | 14.1.4 | List of Abbreviations | 14.1.4 List of Abbreviations AE adverse event ALT alanine aminotransferase anti-HCV antibody to hepatitis C virus AST aspartate aminotransferase AUC area under the plasma concentration-time curve AUC24 area under the plasma concentration-time curve from 0 to 24 hours AUCτ area under the plasma concentration-time curve ... | [] |
NCT03224325 | 15.0 | DATA HANDLING AND RECORDKEEPING | 15.0 DATA HANDLING AND RECORDKEEPING The full details of procedures for data handling will be documented in the Data Management Plan. AEs, medical history, and concurrent conditions will be coded using the MedDRA. Drugs will be coded using the World Health Organization Drug Dictionary. | [] |
NCT03224325 | 15.1 | CRFs (Electronic and Paper) | 15.1 CRFs (Electronic and Paper) Completed eCRFs are required for each subject who signs an informed consent. The sponsor or its designee will supply investigative sites with access to eCRFs. The sponsor will make arrangements to train appropriate site staff in the use of the eCRF. These forms are used to transmit the ... | [] |
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