protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT03345836 | 8.1.7 | Safety Analyses | 8.1.7 Safety Analyses Safety analyses will be performed on safety analysis sets (Part 1, Part 2 and Part 3), as defined in Section [8.1.1.2.](#page-124-5) Incidence of AEs, changes in vital signs, physical examination results, and clinical laboratory data will be assessed throughout the study. ECGs will be performed at... | [] |
NCT03345836 | 8.1.8 | Pharmacokinetic and Exposure-Response Analyses | 8.1.8 Pharmacokinetic and Exposure-Response Analyses Individual upadacitinib plasma concentrations at each study visit will be tabulated and summarized with appropriate statistical methods. Data from this study may be combined with data from other studies for the population PK and exposure-response analyses. Population... | [] |
NCT03345836 | 8.2 | Determination of Sample Size | 8.2 Determination of Sample Size The co-primary endpoints are the proportion of subjects with clinical remission per PROs (EU/EMA) and per CDAI (US/FDA) at Week 12 and the proportion of subjects who achieve endoscopic response at Week 12. Sample size calculation is based on the maximum sample size needed to detect trea... | [] |
NCT03345836 | 8.3 | Randomization Methods | 8.3 Randomization Methods A total of 495 subjects will be randomized in Part 1 of the study in a 2:1 ratio to upadacitinib 45 mg QD or matching placebo (330 subjects for upadacitinib 45 mg dose group and 165 for placebo group). Randomization will be stratified by baseline corticosteroid use (yes or no), endoscopic dise... | [] |
NCT03345836 | 9.0 | Ethics | 9.0 Ethics | [] |
NCT03345836 | 9.1 | Independent Ethics Committee (IEC) or Institutional Review Board (IRB) | 9.1 Independent Ethics Committee (IEC) or Institutional Review Board (IRB) Good Clinical Practice (GCP) requires that the clinical protocol, any protocol amendments, the Investigator's Brochure, the informed consent and all other forms of subject information related to the study (e.g., advertisements used to recruit su... | [] |
NCT03345836 | 9.2 | Ethical Conduct of the Study | 9.2 Ethical Conduct of the Study The study will be conducted in accordance with the protocol, ICH guidelines, applicable regulations and guidelines governing clinical study conduct and the ethical principles that  have their origin in the Declaration of Helsinki. Responsibilities of the clinica... | [] |
NCT03345836 | 9.3 | Subject Information and Consent | 9.3 Subject Information and Consent The investigator or his/her representative will explain the nature of the study to the subject, and answer all questions regarding this study. Prior to any study-related screening procedures being performed on the subject, the informed consent statement will be reviewed and signed an... | [] |
NCT03345836 | 9.3.1 | Informed Consent Form and Explanatory Material | 9.3.1 Informed Consent Form and Explanatory Material In Japan, the principal investigator will prepare the consent form and explanatory material required to obtain subject's consent to participate in the study with the cooperation of the sponsor and will revise these documents as required. The prepared or revised conse... | [] |
NCT03345836 | 9.3.2 | Revision of the Consent Form and Explanatory Material | 9.3.2 Revision of the Consent Form and Explanatory Material In Japan, when important new information related to the subject's consent becomes available, the principal investigator will revise the consent form and explanatory material based on the information without delay and will obtain the approval of the IRB prior t... | [] |
NCT03345836 | 10.0 | Source Documents and Case Report Form Completion | 10.0 Source Documents and Case Report Form Completion | [] |
NCT03345836 | 10.1 | Source Documents | 10.1 Source Documents Source documents are defined as original documents, data and records. This may include hospital records, clinical and office charts, laboratory data/information, subjects' diaries or evaluation checklists, pharmacy dispensing and other records, recorded data from automated instruments, microfiches... | [] |
NCT03345836 | 10.2 | Electronic Case Report Forms (eCRF) | 10.2 Electronic Case Report Forms (eCRF) eCRFs must be completed for each subject screened/enrolled in this study. These forms will be used to transmit information collected during the study to AbbVie and regulatory authorities, as applicable. The CRF data for this study are being collected with an EDC system called Ra... | [] |
NCT03345836 | 10.3 | Electronic Patient Reported Outcomes (ePRO) | 10.3 Electronic Patient Reported Outcomes (ePRO) Patient reported data must be completed for each subject screened/enrolled in this study. Some of these data are being collected with an Electronic Patient Reported Outcome (ePRO) system called Trialmax, provided by the technology vendor CRF Health of Plymouth Meeting, P... | [
"Diary Based",
"Tablet Based"
] |
NCT03345836 | 11.0 | Data Quality Assurance | 11.0 Data Quality Assurance To ensure data integrity and subject safety, a study monitor will, throughout the study, verify that all subjects signed agreement of informed consent prior to any study-specific procedures being conducted. The study monitor will confirm that the investigator is conducting the study in compl... | [] |
NCT03345836 | 12.0 | Use of Information | 12.0 Use of Information All information concerning upadacitinib and AbbVie operations, such as AbbVie patent applications, formulas, manufacturing processes, basic scientific data, or formulation  information, supplied by AbbVie and not previously published is considered confidential informatio... | [] |
NCT03345836 | 13.0 | Completion of the Study | 13.0 Completion of the Study The investigator will conduct the study in compliance with the protocol and complete the study within the timeframe specified in the contract between the Investigator (Director of the Site in Japan) and AbbVie. Continuation of this study beyond this date must be mutually agreed upon in writ... | [] |
NCT03345836 | 14.0 | Investigator's Agreement | 14.0 Investigator's Agreement - 1. I have received and reviewed the Investigator's Brochure for upadacitinib. - 2. I have read this protocol and agree that the study is ethical. - 3. I agree to conduct the study as outlined and in accordance with all applicable regulations and guidelines. - 4. I agree to maintain the c... | [] |
NCT03345836 | 15.0 | Reference List | 15.0 Reference List - 1. Hanauer SB, Sandborn W; Practice Parameters Committee of the American College of Gastroenterology. Management of Crohn's disease in adults. Am J Gastroenterol. 2001;96(3):635-43. - 2. Loftus EV Jr. Clinical epidemiology of inflammatory bowel disease: incidence, prevalence, and environmental inf... | [
"Appendix A. Responsibilities of the Clinical Investigator",
"Appendix B. List of Protocol Signatories",
"Appendix C. Study Activities",
"Appendix D. Latent TB Risk Factor Assessment Form Example",
"Appendix E. Patient Reported Outcomes Descriptions",
"IBDQ – Inflammatory Bowel Disease Questionnaire",
"... |
NCT03357471 | 1 | SUMMARY | 1 SUMMARY RA0098 is a multicenter, open-label, Phase 3 study of the e-Device in US subjects with rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), or Crohn's disease (CD). The e-Device offers improved convenience with an enhanced, reusable electromechanical injector that provides full e... | [] |
NCT03357471 | 2 | INTRODUCTION | 2 INTRODUCTION Cimzia (certolizumab pegol [CZP]) is an anti-TNFα humanized PEGylated Fab' fragment of a monoclonal antibody. Certolizumab pegol has demonstrated a high affinity for TNFα which has been shown to have a central role in the pathogenesis of RA, AS, PsA, and CD. Certolizumab pegol has received market authori... | [] |
NCT03357471 | 3 | STUDY OBJECTIVES | 3 STUDY OBJECTIVES | [] |
NCT03357471 | 3.1 | Primary objective | 3.1 Primary objective The primary objective of the study is to evaluate the ability of subjects in the Q2W and Q4W groups to safely and effectively self-inject CZP using the e-Device at Visit 2. | [] |
NCT03357471 | 3.2 | Secondary objective | 3.2 Secondary objective The secondary objectives are to evaluate the ability of subjects in the Q2W and Q4W groups to safely and effectively self-inject CZP using the e-Device at Visit 1 and the structural integrity of used cassettes via visual examination. REDACTED COPY Device | [] |
NCT03357471 | 3.3 | Other objectives | 3.3 Other objectives The other objectives are to evaluate: - The functional status of the e-Device following administration of the final study dose (ie, no visual signs of damage, device functions normally with training cassette) normally - Subject experience of self-injection as assessed by the Pain Visual Analog Scal... | [] |
NCT03357471 | 3.4 | Safety objective | 3.4 Safety objective The safety objective is to evaluate the safety of CZP self-injection using the e-Device for CZP self-injection. y safet injection. | [] |
NCT03357471 | 4 | STUDY VARIABLES | 4 STUDY VARIABLES | [] |
NCT03357471 | 4.1 | Study outcome variables 4.1 | 4.1 Study outcome variables 4.1 | [] |
NCT03357471 | 4.1.1 | Primary outcome variable | 4.1.1 Primary outcome variable The primary outcome variable is the proportion (%) of subjects able to self-administer safe and effective injections using the e-Device at Visit 2. Safe and effective self-injection will be evaluated by the HCP and is defined as: Complete Dose Delivery: Subject self-injected the complete ... | [] |
NCT03357471 | 4.1.2 | Secondary outcome variables | 4.1.2 Secondary outcome variables The secondary outcome variables are: - The proportion (%) of subjects able to self-administer safe and effective injections using the e-Device at Visit 1. Safe and effective self-injection will be evaluated by the HCP and is defined as: REDACTED COPY administer injection by - Complete ... | [] |
NCT03357471 | 4.1.3 | Other outcome variables | 4.1.3 Other outcome variables The other outcome variables are: Injection site pain due to self-injection (using a VAS; 100mm) by visit at all visits after selfinjection using the e-Device Subjects on the Q4W dosing regimen who will self-inject twice (2×200mg CZP) at each visit will complete the Pain VAS after the secon... | [] |
NCT03357471 | 4.2 | Safety variables | 4.2 Safety variables The safety variables are: - Occurrence of AEs and ADEs - Vital signs | [] |
NCT03357471 | 5 | STUDY DESIGN | 5 STUDY DESIGN | [] |
NCT03357471 | 5.1 | Study description y | 5.1 Study description y In this Phase 3, open-label study of the e-Device, subjects diagnosed with RA, PsA, or AS (treated on Q2W dosing schedule, Q2W group), or RA, PsA, AS, or CD (treated on a Q4W dosing schedule, Q4W group) will be recruited and evaluated. Subjects in the Q2W and Q4W group should currently be treate... | [] |
NCT03357471 | 5.1.1 | Study duration per subject | 5.1.1 Study duration per subject The study duration for each subject in the Q2W group on the Q2W dosing regimen is 3 weeks. The study duration for each subject in the Q4W group on the Q4W dosing regimen is 5 weeks. Subjects will be required to perform a Safety Follow-Up by phone 1 week after their last study dose of CZ... | [] |
NCT03357471 | 5.1.2 | Planned number of subjects and sites | 5.1.2 Planned number of subjects and sites Approximately 80 subjects who are currently being treated with commercial CZP and are on a stable dosing regimen for at least 3 months will be screened in order to have at least 60 subjects use the e-Device at Visit 1 at approximately 45 sites. The 60 subjects using the e-Devi... | [] |
NCT03357471 | 5.1.3 | Anticipated regions and countries | 5.1.3 Anticipated regions and countries The study is planned to be conducted in the US. | [] |
NCT03357471 | 5.2 | Schedule of study assessments | 5.2 Schedule of study assessments Table 5‒1: Schedule of study assessments for Q2W subjects | Assessments | Visit 1Visit 2(Week 2)(Week 0)(±3 days)ScreeningStudy TreatmentPeriod | | | or variationsFollow-UpaUpa(Week 3)(±3 days) | |----------------------------------------------------------------------------------|------... | [
"Table 5‒1: Schedule of study assessments for Q2W subjects",
"Table 5‒2: Schedule of study assessments for Q4W subjects"
] |
NCT03357471 | 5.3 | Rationale for study design and selection of dose | 5.3 Rationale for study design and selection of dose UCB has developed a reusable e-Device for the self-administration of a sc dose of CZP. The e-Device provides subjects with another option to self-inject their medication. The e-Device offers improved convenience with an enhanced, reusable electromechanical injector t... | [] |
NCT03357471 | 6 | SELECTION AND WITHDRAWAL OF SUBJECTS WITHDR | 6 SELECTION AND WITHDRAWAL OF SUBJECTS WITHDR | [] |
NCT03357471 | 6.1 | Inclusion criteria | 6.1 Inclusion criteria To be eligible to participate in this study, all of the following criteria must be met: study - 1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject. formed b - 2. Subject is considered reliable and cap... | [] |
NCT03357471 | 6.2 | Exclusion criteria | 6.2 Exclusion criteria Subjects are not permitted to enroll in the study if any of the following criteria is met: - 1. Subject is <18 years of age at Visit 1. - 2. Subject has participated in another study of an investigational medicinal product (IMP) or an investigational device) within the previous 3 months or is cur... | [] |
NCT03357471 | 6.3 | Withdrawal criteria | 6.3 Withdrawal criteria Subjects are free to withdraw from the study at any time, without prejudice to their continued care. Subjects should be withdrawn from the study if any of the following events occur: study study - 1. Subject develops an illness that would interfere with his/her continued participation. - 2. Subj... | [] |
NCT03357471 | 7 | IMP AND INVESTIGATIONAL DEVICE | 7 IMP AND INVESTIGATIONAL DEVICE In this study, the term investigational medicinal product (IMP) means the CZP drug substance. The term investigational device means the CZP-cassette and e-Device. | [] |
NCT03357471 | 7.1 | Description of investigational device vestigational l | 7.1 Description of investigational device vestigational l The reusable e-Device (auto-injector and CZP-cassette) is shown in Figure 7‒1. -cassette) Each single-use cassette contains 1 PFS with needle. The needle is covered by a needle cap until the CZP-cassette has been successfully inserted into the e-Device and the c... | [] |
NCT03357471 | 7.1.1 | Instructions for use of investigational e-Device | 7.1.1 Instructions for use of investigational e-Device At Visit 1, prior to the first self-administration with the e-Device, subjects will be trained on proper self-injection technique and will receive and have the opportunity to review e-Device instruction materials that will be included with the e-Device kit. After t... | [] |
NCT03357471 | 7.2 | Treatment to be administered | 7.2 Treatment to be administered Table 7‒1: Treatments to be administered | 7.2 | OPYTreatment to be administered | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT03357471 | 7.3 | Packaging | 7.3 Packaging The site will receive uniquely numbered e-Devices and CZP-cassettes for use in this study. The CZP-cassettes will be provided in the intended final packaging. | [] |
NCT03357471 | 7.4 | Labeling | 7.4 Labeling Clinical drug and investigational device supplies will be labeled in accordance with the current International Council for Harmonisation (ICH) guidelines on Good Clinical Practice (GCP) and Good Manufacturing Practice and will include any locally required statements. If necessary, labels will be translated... | [] |
NCT03357471 | 7.5 | Handling and storage requirements | 7.5 Handling and storage requirements Certolizumab pegol (CZP-cassettes) must be securely stored at 2ºC to 8ºC, ie, in a refrigerator that is either in a locked room or in the pharmacy. Appropriate storage conditions must be ensured by controlled fridge temperature either using automated temperature monitoring and reco... | [] |
NCT03357471 | 7.6 | Drug and device accountability | 7.6 Drug and device accountability The Investigator will receive numbered treatments that will be assigned to eligible subjects by an interactive response technology (IXRS) at Visit 1. All drug administrations will be observed by the Investigator or his/her appropriately trained designee. nvestigator appropriately UCB,... | [] |
NCT03357471 | 7.7 | Procedures for monitoring subject compliance | 7.7 Procedures for monitoring subject compliance As all CZP self-administrations will be scheduled, performed at the site, and observed by the Investigator or his/her designee, monitoring subject compliance is not applicable. | [] |
NCT03357471 | 7.8 | Concomitant medications/treatments | 7.8 Concomitant medications/treatments | [] |
NCT03357471 | 7.8.1 | Permitted concomitant treatments (medications and therapies) | 7.8.1 Permitted concomitant treatments (medications and therapies) Subjects are permitted to continue on their prescribed medical therapy for the disease in accordance with the instructions of their treating physician. Concomitant medications/treatments, including over-the-counter products and supplements, must be reco... | [] |
NCT03357471 | 7.8.2 | Prohibited concomitant treatments (medications and therapies) | 7.8.2 Prohibited concomitant treatments (medications and therapies) Use of topical analgesics at the injection site are prohibited concomitant medications in this study. | [] |
NCT03357471 | 7.9 | Blinding | 7.9 Blinding This is an open-label study. | [] |
NCT03357471 | 7.10 | Randomization and numbering of subjects | 7.10 Randomization and numbering of subjects There will be no randomization in this study. A subject number assigned by an IXRS at Visit 1 will serve as the subject identifier throughout the study. REDACTED COPY study | [] |
NCT03357471 | 8 | STUDY PROCEDURES BY VISIT | 8 STUDY PROCEDURES BY VISIT As the dosing schedule groups (Q2W vs Q4W) are different regarding number of injections (1 CZP injection for Q2W vs 2 CZP injections per administration for Q4W) and study treatment period (2 weeks vs 4 weeks), the schedule of assessments for the 2 subject populations differs. adminis subject... | [] |
NCT03357471 | 8.1 | Visit 1/ Screening and Study Treatment Period | 8.1 Visit 1/ Screening and Study Treatment Period Prior to any study activities, all subjects will be asked to read and sign an Informed Consent form that has been approved by an IRB/IEC and which complies with regulatory requirements. Subjects will be given adequate time to consider any information concerning the stud... | [] |
NCT03357471 | 8.2 | Study procedures by visit for the Q2W group y by | 8.2 Study procedures by visit for the Q2W group y by | [] |
NCT03357471 | 8.2.1 | Visit 2 (Week 2) | 8.2.1 Visit 2 (Week 2) The following procedures will be performed: - Review withdrawal criteria - Measurement of vital signs (BP, pulse, body temperature, RR) - Urine pregnancy test (female subjects of childbearing potential) pregnancy - Contact IXRS - Recording of concomitant medication - Self-administration of CZP us... | [] |
NCT03357471 | 8.3 | Study procedures by visit for the Q4W group REDACTED COPY isit | 8.3 Study procedures by visit for the Q4W group REDACTED COPY isit | [] |
NCT03357471 | 8.3.1 | Visit 2 (Week 4) | 8.3.1 Visit 2 (Week 4) The following procedures will be performed: - Review withdrawal criteria - Measurement of vital signs (BP, pulse, body temperature, RR) - Urine pregnancy test (female subjects of childbearing potential) administration - Contact IXRS - Recording of concomitant medication - Self-administration of C... | [] |
NCT03357471 | 8.4 | Safety Follow-Up | 8.4 Safety Follow-Up A Safety Follow-Up by telephone will be conducted 1 week after the subject's final site visit using the e-Device. Any AEs or ADEs will be recorded. Subjects who are withdrawn from CZP treatment during the course of the study due to pregnancy will be required to perform a safety follow-up telephone ... | [] |
NCT03357471 | 9 | ASSESSMENT OF SELF-INJECTION | 9 ASSESSMENT OF SELF-INJECTION | [] |
NCT03357471 | 9.1 | Injection Site Pain (VAS) | 9.1 Injection Site Pain (VAS) A VAS will be used to assess overall injection pain due to self-injection postinjection at every visit during the Study Treatment Period. Subjects will be required to indicate their injection pain by placing a mark on a 100mm line from 0 (no pain) to 100 (worst possible pain). The VAS will... | [] |
NCT03357471 | 9.2 | Assessment of Self Injection (ASI) sessment | 9.2 Assessment of Self Injection (ASI) sessment The preinjection ASI is composed of 6 items grouped into 2 domains. The postinjection ASI is composed of 44 items grouped into 6 domains. The domains are feeling about injections, selfimage, self-confidence, pain and skin reactions during and after injections, ease of use... | [] |
NCT03357471 | 9.3 | Self-Injection Preference Questionnaire | 9.3 Self-Injection Preference Questionnaire The 9-item Self-Injection Preference Questionnaire was developed, based on patient input, to assess the self-injection experience and patient preference between the e-Device and PFS. The Self-Injection Preference Questionnaire will be completed by the subject at Visit 2 after... | [] |
NCT03357471 | 9.4 | Evaluation of post-use structural integrity of CZP-cassettes | 9.4 Evaluation of post-use structural integrity of CZP-cassettes The used CZP-cassettes will be inspected to determine if the entire dose was delivered based on whether the PFS housed in the CZP-cassette is empty or not (as per primary endpoint). During self-injection, if the skin sensor at the injection port loses con... | [] |
NCT03357471 | 9.5 | Evaluation of post-use structural and functional integrity of the e-Device use integrity | 9.5 Evaluation of post-use structural and functional integrity of the e-Device use integrity Following the subject's final self-administration using the e-Device, the e-Device will be visually inspected for structural integrity and damage (ie, clear evidence of damage/compromised structural integrity—not superficial, c... | [] |
NCT03357471 | 9.6 | Evaluation of safe and effective self-injection aluation s | 9.6 Evaluation of safe and effective self-injection aluation s Safe and effective self-injection will be evaluated by the HCP. Subject self-injection of the complete dose of CZP will be confirmed by a visual inspection of the CZP-cassette(s) which shows the PFS container to be empty. During self-injection, if the skin ... | [] |
NCT03357471 | 10 | ASSESSMENT OF SAFETY | 10 ASSESSMENT OF SAFETY In this study, safety reporting requirements apply to the IMP and to all constituents of the investigational device (including the e-Device auto-injector, and the CZP-cassette) per 21 CFR 312.32, 21 CFR 812.150, and 21 CFR 812.3. Subjects in the study are experienced at self-injection and will b... | [] |
NCT03357471 | 10.1.1.2 | Serious adverse event (IMP) | 10.1.1.2 Serious adverse event (IMP) Once it is determined that a subject experienced an AE, the seriousness of the AE must be determined. An SAE must meet 1 or more of the following criteria: - Death - Life-threatening (Life-threatening does not include a reaction that might have caused death had it occurred in - Sign... | [] |
NCT03357471 | 10.1.1.2.1 | Anticipated serious adverse events (IMP) ticipated events | 10.1.1.2.1 Anticipated serious adverse events (IMP) ticipated events The following Anticipated SAEs are anticipated to occur in the population studied in this protocol at some frequency that is independent of drug exposure. This list does not change the Investigator's obligation to report all SAEs (including Anticipate... | [] |
NCT03357471 | 10.1.1.3 | Adverse events of special interest (IMP) | 10.1.1.3 Adverse events of special interest (IMP) - Serious infections, including opportunistic infections REDACTED COPY - Malignancies, including lymphoma - Congestive heart failure - Demyelinating-like disorders - Aplastic anemia, pancytopenia, thrombocytopenia, neutropenia, and leucopenia topenia, thrombocy - Seriou... | [] |
NCT03357471 | 10.1.2 | Procedures for reporting and recording adverse events (IMP) | 10.1.2 Procedures for reporting and recording adverse events (IMP) "Did you notice anything unusual about your health (since your last visit)?" In addition, the Investigator should review any self-assessment procedures employed in the study. | [] |
NCT03357471 | 10.1.2.1 | Description of adverse events (IMP) | 10.1.2.1 Description of adverse events (IMP) When recording an AE, the Investigator should use the overall diagnosis or syndrome using standard medical terminology, rather than recording individual symptoms or signs. The eCRF and source documents should be consistent. Any discrepancies between the subject's own words o... | [] |
NCT03357471 | 10.1.2.2 | Rule for repetition of an adverse event (IMP) | 10.1.2.2 Rule for repetition of an adverse event (IMP) An increase in the intensity of an AE should lead to the repetition of the AE being reported with: - The outcome date of the first AE that is not related to the natural course of the disease being the same as the start date of the repeated AE, and the outcome of "w... | [] |
NCT03357471 | 10.1.2.3 | Additional procedures for reporting serious adverse events (IMP) ditional | 10.1.2.3 Additional procedures for reporting serious adverse events (IMP) ditional If an SAE is reported, UCB must be informed within 24 hours of receipt of this information by the site (see contact information for SAE reporting listed in the Serious Adverse Event Reporting section at the front of the protocol). The In... | [] |
NCT03357471 | 10.1.3 | Follow up of adverse events (IMP) | 10.1.3 Follow up of adverse events (IMP) An AE should be followed until it has resolved, has a stable sequelae, the Investigator determines that it is no longer clinically significant, or the subject is lost to follow up. This follow-up requirement applies to AEs, SAEs, and AEs of special interest. If an AE is ongoing ... | [] |
NCT03357471 | 10.2.1.2 | Serious adverse event (investigational device) | 10.2.1.2 Serious adverse event (investigational device) Once it is determined that a subject experienced an AE for an investigational device, the seriousness of the AE must be determined. An SAE must meet 1 or more of the following criteria: - Death - Serious deterioration in the health of the subject that results in a... | [] |
NCT03357471 | 10.2.1.3 | Device- or procedure-related | 10.2.1.3 Device- or procedure-related | [] |
NCT03357471 | 10.2.1.3.1 | Adverse device effect (investigational device) verse | 10.2.1.3.1 Adverse device effect (investigational device) verse An adverse device effect (ADE) is an AE related to the use of an investigational device. An ADE must meet 1 or more of the following criteria: REDACTED COPY - Adverse event resulting from insufficiencies or inadequacies in the instructions for use, the dep... | [] |
NCT03357471 | 10.2.1.3.1.1 | Unanticipated adverse device effect (investigational device) | 10.2.1.3.1.1 Unanticipated adverse device effect (investigational device) An unanticipated adverse device effect (UADE) is any ADE that meets 1 or more of the following criteria: any - Serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with a device, if that eff... | [] |
NCT03357471 | 10.2.1.3.2 | Serious adverse device effect (investigational device) | 10.2.1.3.2 Serious adverse device effect (investigational device) A serious adverse device effect (SADE) is an ADE that has resulted in any of the consequences characteristic of a SAE, as described in Section 10.2.1.2. Serious adverse device effects are classified as anticipated (anticipated serious adverse device effe... | [] |
NCT03357471 | 10.2.1.3.3 | Device deficiency (investigational device) | 10.2.1.3.3 Device deficiency (investigational device) A device deficiency is an inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety, or performance. Device deficiencies include malfunctions, use errors, and inadequate labeling. | [] |
NCT03357471 | 10.2.2 | Procedures for reporting and recording adverse events (investigational device), adverse device effects, and device deficiencies | 10.2.2 Procedures for reporting and recording adverse events (investigational device), adverse device effects, and device deficiencies The subject will be given the opportunity to report AEs, ADEs, and device deficiencies spontaneously. A general prompt will also be given at each study visit to detect AEs, ADEs, and de... | [] |
NCT03357471 | 10.2.2.1 | Adverse events | 10.2.2.1 Adverse events Details for completion of the Adverse Event eCRF (including judgment of relationship to Investigational Device or Study procedure) are described in the eCRF Completion Guidelines. hing Deficiency | [] |
NCT03357471 | 10.2.2.1.1 | Serious adverse events | 10.2.2.1.1 Serious adverse events See Section 10.1.1.2 for details. | [] |
NCT03357471 | 10.2.3 | Follow up of adverse events (investigational device) REDACTED COPY | 10.2.3 Follow up of adverse events (investigational device) REDACTED COPY See Section 10.1.3. | [] |
NCT03357471 | 10.2.3.1 | Device-related | 10.2.3.1 Device-related | [] |
NCT03357471 | 10.2.3.1.1 | Reporting of adverse device effects | 10.2.3.1.1 Reporting of adverse device effects An Investigator Adverse Device Effect and Device Deficiency Form will be provided to the Investigator. The Investigator Adverse Device Effect and Device Deficiency Form must be completed in English. . Deficiency An Investigator shall submit to UCB a report of any adverse d... | [] |
NCT03357471 | 10.2.3.1.1.1 | Reporting of unanticipated adverse device effects by the Investigator 10.2.3.1.1.1 | 10.2.3.1.1.1 Reporting of unanticipated adverse device effects by the Investigator 10.2.3.1.1.1 An Investigator shall submit a report of any unanticipated adverse device effect occurring during an investigation to: an - UCB within 24h, UCB will conduct an evaluation of the reported unanticipated adverse device effect a... | [] |
NCT03357471 | 10.2.3.1.2 | Reporting of serious adverse device effects | 10.2.3.1.2 Reporting of serious adverse device effects | [] |
NCT03357471 | 10.2.3.1.2.1 | Reporting of serious adverse device effect including device deficiencies with risk of SAE | 10.2.3.1.2.1 Reporting of serious adverse device effect including device deficiencies with risk of SAE If an SADE or a device deficiency that could have led to a serious adverse event, if: - Either suitable action had not been taken or - Intervention had not been made or - Circumstances had been less fortunate is repor... | [] |
NCT03357471 | 10.2.3.1.3 | Reporting of device deficiencies y.deficiency | 10.2.3.1.3 Reporting of device deficiencies y.deficiency If a device deficiency related to the identity, quality, durability, reliability, safety, or performance of the investigational device is reported (even if the investigational device was not used), UCB must be informed within 1 business day of receipt of this inf... | [] |
NCT03357471 | 10.2.3.2 | Rule for repetition of an adverse device effect and/or device deficiency | 10.2.3.2 Rule for repetition of an adverse device effect and/or device deficiency See Section 10.1.2.2 for details. | [] |
NCT03357471 | 10.3 | Pregnancy | 10.3 Pregnancy If an Investigator is notified that a subject has become pregnant before or after the first dose IMP via e-Device, the Investigator must immediately notify UCB's Patient Safety (PS) department by providing the completed Pregnancy Report and Outcome form (for contact details see Serious Adverse Event repo... | [] |
NCT03357471 | 10.4 | Suspected transmission of an infectious agent | 10.4 Suspected transmission of an infectious agent For the purposes of reporting, any suspected transmission of an infectious agent via a medicinal product should be considered as an SAE; such cases must be reported immediately, recorded in the AE module of the eCRF, and followed as any other SAE. Any organism, virus, ... | [] |
NCT03357471 | 10.5 | Overdose of investigational medicinal product erdose | 10.5 Overdose of investigational medicinal product erdose Excessive dosing (beyond that prescribed in the protocol and including overdose) should be recorded in the eCRF. Any SAE or nonserious AE associated with excessive dosing must be followed as any other SAE or nonserious AE. These events are only considered AEs or... | [] |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.