protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT05416164 | 9.2 | Recruitment and consent | 9.2 Recruitment and consent Patients eligible for the study will be contacted during the pre-operative outpatient clinical appointment by a specialist. Patients will receive oral information and a patient information letter as well as the informed consent form (see attachment). Patients will be given enough time to con... | [] |
NCT05416164 | 9.3 | Objection by minors or incapacitated subjects | 9.3 Objection by minors or incapacitated subjects Not applicable. | [] |
NCT05416164 | 9.4 | Benefits and risks assessment, group relatedness | 9.4 Benefits and risks assessment, group relatedness Patients participating in this study will be spared side-effects associated with radiotherapy. Patients in which radiotherapy is omitted may have a higher risk of developing a local recurrence. The majority of local recurrences can be treated with breast conserving t... | [] |
NCT05416164 | 9.5 | Compensation for injury | 9.5 Compensation for injury The sponsor/investigator has a liability insurance which is in accordance with article 7 of the WMO. The sponsor (also) has an insurance which is in accordance with the legal requirements in the Netherlands (Article 7 WMO). This insurance provides cover for damage to research subjects throug... | [] |
NCT05416164 | 9.6 | Incentives | 9.6 Incentives Not applicable. Version number: 9.0 September 2024 25 of 33 | [] |
NCT05416164 | 10 | ADMINISTRATIVE ASPECTS, MONITORING AND PUBLICATION | 10. ADMINISTRATIVE ASPECTS, MONITORING AND PUBLICATION | [] |
NCT05416164 | 10.1 | Handling and storage of data and documents | 10.1 Handling and storage of data and documents The central data management will be performed by the Netherlands Cancer Institute-Antoni van Leeuwenhoek. Registration will be done after the written informed consent is obtained and after verification of eligibility. After the written informed consent is obtained, patien... | [] |
NCT05416164 | 10.2 | Monitoring and Quality Assurance | 10.2 Monitoring and Quality Assurance The study will be monitored according to ICH GCP, either on site or remote. This study will be considered as a low risk study. A monitoring plan specific to the study and describing the nature and frequency of the monitoring will be written by the appointed monitor and approved by ... | [] |
NCT05416164 | 10.3 | Amendments | 10.3 Amendments Version number: 9.0 September 2024 26 of 33 Amendments are changes made to the research after a favourable opinion by the accredited METC has been given. All amendments will be notified to the METC that gave a favourable opinion. Non-substantial amendments will not be notified to the accredited METC and... | [] |
NCT05416164 | 10.4 | Annual progress report | 10.4 Annual progress report The sponsor/investigator will submit a summary of the progress of the trial to the accredited METC once a year. Information will be provided on the date of inclusion of the first subject, numbers of subjects included and numbers of subjects that have completed the trial, serious adverse even... | [] |
NCT05416164 | 10.5 | Temporary halt and (prematurely) end of study report | 10.5 Temporary halt and (prematurely) end of study report The investigator/sponsor will notify the accredited METC of the end of the study within a period of 8 weeks. The end of the study is defined as the last patient's last visit. The sponsor will notify the METC immediately of a temporary halt of the study, includin... | [] |
NCT05416164 | 10.6 | Public disclosure and publication policy | 10.6 Public disclosure and publication policy The data will be published by the project leader and investigators mentioned in this protocol. | [] |
NCT05416164 | 11 | STRUCTURED RISK ANALYSIS | 11.STRUCTURED RISK ANALYSIS Not applicable. | [] |
NCT05416164 | 12 | REFERENCES | 12. REFERENCES - 1. Murphy, B. L., and Boughey, J. C. (2018) ASO Author Reflections: Changes in Use of Neoadjuvant Chemotherapy Over Time-Highest Rates of Use Now in Triple-Negative and HER2+ Disease. Ann Surg Oncol 25, 695-696 - 2. Straver, M. E., Rutgers, E. J., Rodenhuis, S., Linn, S. C., Loo, C. E., Wesseling, J., ... | [] |
NCT05436912 | 16.1 | Study Information | 16.1. Study Information | [] |
NCT05436912 | 16.1.1 | Protocol and Amendments | 16.1.1. Protocol and Amendments 20 May 2020 Page 1 of 163
Protocol Open-label, Nonrandomized, Single-dose, Parallel-group, Safety, Tolerance, and Pharmacokinetic Study of LOX0-292 Administered to Fasted Hepatically Impaired Male and Female Subjects and Fasted Matched-control Healthy Subjects > Protocol Status: Final A... | [
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NCT05498701 | 1 | PROTOCOL SUMMARY | 1. PROTOCOL SUMMARY | [] |
NCT05498701 | 1.1 | Synopsis | 1.1. Synopsis Protocol Title: A Phase 1, Open-Label, Randomized, Crossover, Single Dose Study to Determine the Bioequivalence of 12.2 mg Tafamidis Free Acid Tablets and Commercial 20 mg Tafamidis Meglumine Capsules Administered Under Fasted Conditions and the Effect of Food on Oral Bioavailability of 12.2 mg Tafamidis ... | [
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NCT05498701 | 1.2 | Schema | 1.2. Schema Not applicable. | [] |
NCT05498701 | 1.3 | Schedule of Activities | 1.3. Schedule of Activities The SoA table provides an overview of the protocol visits and procedures. Refer to the [STUDY ASSESSMENTS AND](#page-35-2) [PROCEDURES](#page-35-2) section of the protocol for detailed information on each procedure and assessment required for compliance with the protocol. The investigator ma... | [
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NCT05498701 | 2 | INTRODUCTION | 2. INTRODUCTION A 12.2 milligram (mg) tafamidis free acid tablet is being developed to replace the current commercial 20 mg tafamidis meglumine dosage formulation. | [] |
NCT05498701 | 2.1 | Study Rationale | 2.1. Study Rationale The purpose of the study is to determine if a 12.2 mg tafamidis free acid tablet (Test) formulation is bioequivalent to the commercial 20 mg tafamidis meglumine soft gelatin capsule (Reference) and to estimate the effect of food on the bioavailability of the 12.2 mg tafamidis free acid tablet. | [] |
NCT05498701 | 2.2 | Background | 2.2. Background Amyloidosis is a severely debilitating, and ultimately fatal, systemic condition induced by the accumulation of an insoluble fibrillar protein (amyloid) within tissues in amounts sufficient to impair normal function. The tafamidis salt (tafamidis meglumine, Vyndaqel®) 20 mg QD is approved in more than 4... | [] |
NCT05498701 | 2.3 | Benefit/Risk Assessment | 2.3. Benefit/Risk Assessment Tafamidis is not expected to provide any clinical benefit to healthy participants. This study is designed primarily to generate BE data to support a formulation change. In completed clinical studies, tafamidis was determined to be well-tolerated and to have an acceptable safety profile. Mor... | [] |
NCT05498701 | 2.3.1 | Risk Assessment | 2.3.1. Risk Assessment | PotentialRiskofClinicalSignificance | SummaryofData/RationaleforRisk | MitigationStrategy | | | | |-------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------... | [] |
NCT05498701 | 2.3.2 | Overall Benefit/Risk Conclusion | 2.3.2. Overall Benefit/Risk Conclusion Taking into account the measures to minimize risk to study participants, the potential risks identified in association with tafamidis or study procedures are justified by the anticipated benefits that may be afforded to patients with ATTR-CM and/or ATTR-PN. | [] |
NCT05498701 | 3 | OBJECTIVES AND ENDPOINTS | 3. OBJECTIVES AND ENDPOINTS | Objectives | Endpoints | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT05498701 | 4 | STUDY DESIGN | 4. STUDY DESIGN | [] |
NCT05498701 | 4.1 | Overall Design | 4.1. Overall Design This study will be a Phase 1, open label, randomized, 3-way crossover, single dose study to determine the bioequivalence of PF-06291826 (tafamidis) 12.2 mg tafamidis free acid tablets versus commercial 20 mg tafamidis meglumine capsules administered under fasted conditions and to estimate the effect... | [] |
NCT05498701 | 4.2 | Scientific Rationale for Study Design | 4.2. Scientific Rationale for Study Design This study was designed to characterize the BE of a 12.2 mg tafamidis free acid tablet compared to the commercial 20 mg tafamidis meglumine soft gelatin capsule in healthy participants under fasted conditions and to estimate the effect of food on the 12.2 mg tafamidis free aci... | [] |
NCT05498701 | 4.2.1 | Choice of Contraception/Barrier Requirements | 4.2.1. Choice of Contraception/Barrier Requirements Tafamidis is approved for use in ATTR-PN and ATTR-CM without any contraceptive precautions. There is no suspicion of human teratogenicity based on the intended pharmacology. | [] |
NCT05498701 | 4.2.2 | Collection of Retained Research Samples | 4.2.2. Collection of Retained Research Samples Retained Research Samples will be collected and stored for further analyses which may, for example, provide greater understanding of the study intervention. | [] |
NCT05498701 | 4.3 | Justification for Dose | 4.3. Justification for Dose The 12.2 mg free acid tablet contains the same API as the tafamidis meglumine 20 mg formulation. One tafamidis meglumine 20 mg capsule contains 12.2 mg of tafamidis free acid. Tafamidis meglumine 20 mg is currently available as a soft gelatin capsule approved for the treatment of ATTR-PN (20... | [] |
NCT05498701 | 4.4 | End of Study Definition | 4.4. End of Study Definition The end of the study is defined as the date of the last visit of the last participant in the study or last scheduled procedure shown in the [SoA](#page-13-0) for the last participant in the trial. A participant is considered to have completed the study if they have completed all periods of ... | [] |
NCT05498701 | 5 | STUDY POPULATION | 5. STUDY POPULATION This study can fulfill its objectives only if appropriate participants are enrolled, including participants across diverse and representative racial and ethnic backgrounds. Use of a prescreening tool is utilized for study recruitment purposes, it will include collection of information that reflects ... | [] |
NCT05498701 | 5.1 | Inclusion Criteria | 5.1. Inclusion Criteria Participants are eligible to be included in the study only if all of the following criteria apply:
Age and Sex: - 1. Participants aged 18 years or older (or the minimum age of consent in accordance with local regulations) at screening. - 2. Healthy female participants of nonchildbearing potenti... | [
"Age and Sex:",
"Other Inclusion Criteria:"
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NCT05498701 | 5.2 | Exclusion Criteria | 5.2. Exclusion Criteria Participants are excluded from the study if any of the following criteria apply:
Medical Conditions: 1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including ... | [
"Medical Conditions:",
"Prior/Concomitant Therapy:",
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NCT05498701 | 5.3 | Lifestyle Considerations | 5.3. Lifestyle Considerations The following guidelines are provided: | [] |
NCT05498701 | 5.3.1 | Meals and Dietary Restrictions | 5.3.1. Meals and Dietary Restrictions - Participants must abstain from all food and drink (except water) at least 4 hours prior to any safety laboratory evaluations and 10 hours prior to the collection of the predose PK sample (Treatments A and B). - Water is permitted until 1 hour prior to study intervention administr... | [] |
NCT05498701 | 5.3.2 | Caffeine, Alcohol, and Tobacco | 5.3.2. Caffeine, Alcohol, and Tobacco - Participants will abstain from caffeine-containing products for 24 hours prior to the start of dosing until collection of the final PK sample of each study period. - Participants will abstain from alcohol for 24 hours prior (or as specified above for red wine) to admission to the... | [] |
NCT05498701 | 5.3.3 | Activity | 5.3.3. Activity - Participants will abstain from strenuous exercise (eg, heavy lifting, weight training, calisthenics, aerobics) for at least 48 hours prior to each blood collection for clinical laboratory tests. Walking at a normal pace will be permitted; - In order to standardize the conditions on PK sampling days, p... | [] |
NCT05498701 | 5.4 | Screen Failures | 5.4. Screen Failures Screen failures are defined as participants who consent to participate in the clinical study but are not subsequently enrolled in the study. Screen failure data are collected and remain as source and are not reported on the CRF. Individuals who do not meet the criteria for participation in this stu... | [] |
NCT05498701 | 6 | STUDY INTERVENTION(S) AND CONCOMITANT THERAPY | 6. STUDY INTERVENTION(S) AND CONCOMITANT THERAPY Study interventions are all prespecified investigational and medical devices, and other interventions (eg, surgical and behavioral) intended to be administered to the study participants during the study conduct. For the purposes of this protocol, study intervention refer... | [] |
NCT05498701 | 6.1 | Study Intervention(s) Administered | 6.1. Study Intervention(s) Administered Eligible participants who continue to meet entry criteria will be admitted to the CRU on Day -1 and will be required to stay in the CRU for 8 overnight stays in each period. All participants will be discharged from the CRU following completion of the discharge evaluation, which i... | [] |
NCT05498701 | 6.1.1 | Administration | 6.1.1. Administration On Day 1 of each period each participant will receive either tafamidis 12.2 mg tablet under fasting (Treatment A) or fed (Treatment C) conditions or tafamidis meglumine 20 mg soft gelatin capsule (Treatment B) under fasting conditions. Following an overnight fast of at least 10 hours, participants... | [] |
NCT05498701 | 6.2 | Preparation, Handling, Storage, and Accountability | 6.2. Preparation, Handling, Storage, and Accountability - 1. The investigator or designee must confirm that appropriate conditions (eg, temperature) have been maintained during transit for all study interventions received and any discrepancies are reported and resolved before use of the study intervention. - 2. Only pa... | [] |
NCT05498701 | 6.2.1 | Preparation and Dispensing | 6.2.1. Preparation and Dispensing Within this protocol, preparation refers to the investigator site activities performed to make the study intervention ready for administration or dispensing to the participant by qualified staff. Dispensing is defined as the provision of study intervention, concomitant treatments, and ... | [] |
NCT05498701 | 6.3 | Assignment to Study Intervention | 6.3. Assignment to Study Intervention The investigator will assign participant numbers to the participants as they are screened for the study. Pfizer will provide a randomization schedule to the investigator and, in accordance with the randomization numbers, the participant will receive the study treatment regimen assi... | [] |
NCT05498701 | 6.4 | Blinding | 6.4. Blinding This is an open-label study. | [] |
NCT05498701 | 6.4.1 | Blinding of Participants | 6.4.1. Blinding of Participants Participants will be unblinded to their assigned study intervention. | [] |
NCT05498701 | 6.4.2 | Blinding of Site Personnel | 6.4.2. Blinding of Site Personnel Investigators and other site staff will be unblinded to participants' assigned study intervention. | [] |
NCT05498701 | 6.4.3 | Blinding of the Sponsor | 6.4.3. Blinding of the Sponsor Sponsor staff will be unblinded to participants' assigned study intervention. | [] |
NCT05498701 | 6.5 | Study Intervention Compliance | 6.5. Study Intervention Compliance Participants will receive study intervention directly from the investigator or designee, under medical supervision. The date and time of each dose administered in the clinic will be recorded in the source documents and recorded in the CRF. The dose of study intervention and study part... | [] |
NCT05498701 | 6.6 | Dose Modification | 6.6. Dose Modification As this is a single-dose study, no dose modification is permitted. | [] |
NCT05498701 | 6.7 | Continued Access to Study Intervention After the End of the Study | 6.7. Continued Access to Study Intervention After the End of the Study No study intervention will be provided to participants at the end of their study participation. | [] |
NCT05498701 | 6.8 | Treatment of Overdose | 6.8. Treatment of Overdose For this study, any dose of PF-06291826 greater than 20 mg tafamidis meglumine or 12.2 mg tafamidis free acid within a 24-hour time period will be considered an overdose. There is no specific treatment for an overdose. In the event of an overdose, the investigator should: - 1. Contact the stu... | [] |
NCT05498701 | 6.9 | Prior and Concomitant Therapy | 6.9. Prior and Concomitant Therapy Use of prescription or nonprescription drugs and dietary and herbal supplements are prohibited within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention. Limited use of nonprescription medications that are not believed to affect participant safe... | [] |
NCT05498701 | 7 | DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT DISCONTINUATION/WITHDRAWAL | 7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT DISCONTINUATION/WITHDRAWAL | [] |
NCT05498701 | 7.1 | Discontinuation of Study Intervention | 7.1. Discontinuation of Study Intervention Since this is a single-dose study, this section is not applicable. | [] |
NCT05498701 | 7.1.1 | ECG Changes | 7.1.1. ECG Changes If a clinically significant finding is identified (including, but not limited to, changes from baseline in QTcF after enrollment), the investigator or qualified designee will determine if the participant can continue in the study and if any change in participant management is needed. This review of t... | [] |
NCT05498701 | 7.1.2 | COVID-19 | 7.1.2. COVID-19 If a participant is diagnosed with COVID-19 during the study, it should be reported as an AE or SAE (as appropriate) and appropriate medical intervention should be provided. | [] |
NCT05498701 | 7.2 | Participant Discontinuation/Withdrawal From the Study | 7.2. Participant Discontinuation/Withdrawal From the Study A participant may withdraw from the study at any time at their own request. Reasons for discontinuation from the study include the following: - Refused further follow-up - Lost to follow-up - Death - Study terminated by Sponsor At the time of discontinuing from... | [] |
NCT05498701 | 7.2.1 | Withdrawal of Consent | 7.2.1. Withdrawal of Consent Participants who request to discontinue receipt of study intervention will remain in the study and must continue to be followed for protocol-specified follow-up procedures. The only exception to this is when a participant specifically withdraws consent for any further contact with them or p... | [] |
NCT05498701 | 7.3 | Lost to Follow-up | 7.3. Lost to Follow-up A participant will be considered lost to follow-up if the participant repeatedly fails to return for scheduled visits and is unable to be contacted by the study site. The following actions must be taken if a participant fails to return to the clinic for a required study visit: - • The site must a... | [] |
NCT05498701 | 8 | STUDY ASSESSMENTS AND PROCEDURES | 8. STUDY ASSESSMENTS AND PROCEDURES | [] |
NCT05498701 | 8.1 | Administrative and Baseline Procedures | 8.1. Administrative and Baseline Procedures The investigator (or an appropriate delegate at the investigator site) must obtain a signed and dated ICD before performing any study-specific procedures. Study procedures and their timing are summarized in the [SoA.](#page-13-0) Protocol waivers or exemptions are not allowed... | [] |
NCT05498701 | 8.2 | Efficacy Assessments | 8.2. Efficacy Assessments Analysis of efficacy is not applicable to this study.    | [] |
NCT05498701 | 8.3.5 | COVID-19 Specific Assessments | 8.3.5. COVID-19 Specific Assessments Participants will be tested for COVID-19 infection per local site procedures prior to being admitted to the clinic for confinement and a subsequent COVID-19 test will be performed after 4 days (ie, upon completion of 4 × 24 hours in house), or if they develop COVID-19-like symptoms.... | [] |
NCT05498701 | 8.5 | Pharmacokinetics | 8.5. Pharmacokinetics | [] |
NCT05498701 | 8.5.1 | Plasma for Analysis of Tafamidis | 8.5.1. Plasma for Analysis of Tafamidis Blood samples of approximately 4 mL, to provide approximately 1.5 mL, will be collected for measurement of plasma concentrations of tafamidis as specified in the [SoA.](#page-13-0) Instructions for the collection and handling of biological samples will be provided in the laborato... | [] |
NCT05498701 | 8.6 | Genetics | 8.6. Genetics | [] |
NCT05498701 | 8.6.1 | Specified Genetics | 8.6.1. Specified Genetics Specified genetic analyses are not evaluated in this study.  | [] |
NCT05498701 | 8.7 | Biomarkers | 8.7. Biomarkers Biomarkers are not evaluated in this study. | [] |
NCT05498701 | 8.7.1 | Specified Gene Expression (RNA) Research | 8.7.1. Specified Gene Expression (RNA) Research Specified gene expression (RNA) research is not included in this study. | [] |
NCT05498701 | 8.7.2 | Specified Protein Research | 8.7.2. Specified Protein Research Specified protein research is not included in this study. | [] |
NCT05498701 | 8.7.3 | Specified Metabolomic Research | 8.7.3. Specified Metabolomic Research Specified metabolomic research is not included in this study. | [] |
NCT05498701 | 8.8 | Immunogenicity Assessments | 8.8. Immunogenicity Assessments Immunogenicity assessments are not included in this study. | [] |
NCT05498701 | 8.9 | Health Economics | 8.9. Health Economics Health economics/medical resource utilization and health economics parameters are not evaluated in this study. | [] |
NCT05498701 | 9 | STATISTICAL CONSIDERATIONS | 9. STATISTICAL CONSIDERATIONS Detailed methodology for summary and statistical analyses of the data collected in this study is outlined here and further detailed in the SAP, which will be maintained by the sponsor. The SAP may modify what is outlined in the protocol where appropriate; however, any major modifications o... | [] |
NCT05498701 | 9.1 | Statistical Hypotheses | 9.1. Statistical Hypotheses The alternative hypothesis of bioequivalence (H1: qL ≤ mT - mR ≤ qU), and the null hypothesis of inequivalence (Ho: mT - mR qU) can be expressed as the following 2 separate one-sided hypotheses: HoA: mT - mR qU H1B: mT - mR ≤ qU where mT and mR represent the average bioavailability on a log ... | [] |
NCT05498701 | 9.2 | Analysis Sets | 9.2. Analysis Sets For purposes of analysis, the following analysis sets are defined: | ParticipantAnalysis | Description | |-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT05498701 | 9.3 | Statistical Analyses | 9.3. Statistical Analyses The SAP will be developed and finalized before any analyses are performed and will describe the analyses and procedures for accounting for missing, unused, and spurious data. This section is a summary of the planned statistical analyses of the primary and secondary endpoints. | [] |
NCT05498701 | 9.3.1 | Pharmacokinetic Analyses | 9.3.1. Pharmacokinetic Analyses | [] |
NCT05498701 | 9.3.1.1 | Derivation of Pharmacokinetic Parameters | 9.3.1.1. Derivation of Pharmacokinetic Parameters Plasma PK parameters for tafamidis will be derived (as data permit) from the concentrationtime data using standard noncompartmental methods as outlined in Table 4. Actual PK sampling times will be used in the derivation of PK parameters. In the case that actual PK sampl... | [] |
NCT05498701 | 9.3.2 | Statistical Methods for PK Data | 9.3.2 Statistical Methods for PK Data For assessment of the bioequivalence objective of the study (Periods 1 and 2), natural log transformed AUCinf, AUClast, CCI and Cmax will be analyzed separately using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a rand... | [] |
NCT05498701 | 9.3.2 | Safety Analyses | 9.3.2. Safety Analyses All safety analyses will be performed on the safety population. AEs, ECGs, BP, pulse rate, and safety laboratory data will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of participants. Any clinical laboratory, ECG, BP, and pulse rate abnormalities of pote... | [] |
NCT05498701 | 9.4 | Interim Analyses | 9.4. Interim Analyses No interim analysis will be conducted for this study. As this is an open-label study, the sponsor may conduct unblinded reviews of the data during the course of the study for the purpose of safety assessment and/or supporting clinical development. | [] |
NCT05498701 | 9.5 | Sample Size Determination | 9.5. Sample Size Determination The sample size of 22 participants (11 participants per sequence in the fasted arms) to ensure a minimum of 18 PK evaluable participants for this 3-way crossover will provide 97% power that the 90% confidence interval for the ratio of Test to Reference for AUCinf will lie within the accep... | [] |
NCT05498701 | 10 | SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS | 10. SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS | [] |
NCT05498701 | 10.1 | Appendix 1: Regulatory, Ethical, and Study Oversight Considerations | 10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations | [] |
NCT05498701 | 10.1.1 | Regulatory and Ethical Considerations | 10.1.1. Regulatory and Ethical Considerations This study will be conducted in accordance with the protocol and with the following: - Consensus ethical principles derived from international guidelines, including the Declaration of Helsinki and CIOMS International Ethical Guidelines; - Applicable ICH GCP guidelines; - Ap... | [] |
NCT05498701 | 10.1.1.1 | Reporting of Safety Issues and Serious Breaches of the Protocol or ICH GCP | 10.1.1.1. Reporting of Safety Issues and Serious Breaches of the Protocol or ICH GCP In the event of any prohibition or restriction imposed (ie, clinical hold) by an applicable regulatory authority in any area of the world, or if the investigator is aware of any new information that might influence the evaluation of th... | [] |
NCT05498701 | 10.1.2 | Informed Consent Process | 10.1.2. Informed Consent Process The investigator or the investigator's representative will explain the nature of the study, including the risks and benefits, to the participant and answer all questions regarding the study. The participant should be given sufficient time and opportunity to ask questions and to decide w... | [] |
NCT05498701 | 10.1.3 | Data Protection | 10.1.3. Data Protection All parties will comply with all applicable laws, including laws regarding the implementation of organizational and technical measures to ensure protection of participant data. Participants' personal data will be stored at the study site in encrypted electronic and/or paper form and will be pass... | [] |
NCT05498701 | 10.1.4 | Committees Structure | 10.1.4. Committees Structure Not applicable. | [] |
NCT05498701 | 10.1.4.1 | Data Monitoring Committee | 10.1.4.1. Data Monitoring Committee This study will not use an E-DMC. | [] |
NCT05498701 | 10.1.5 | Dissemination of Clinical Study Data | 10.1.5. Dissemination of Clinical Study Data Pfizer fulfills its commitment to publicly disclose clinical study results through posting the results of studies on [www.clinicaltrials.gov](http://www.clinicaltrials.gov/) (ClinicalTrials.gov), the EudraCT/CTIS, and/or [www.pfizer.com,](http://www.pfizer.com/) and other pu... | [
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NCT05498701 | 10.1.6 | Data Quality Assurance | 10.1.6. Data Quality Assurance All participant data relating to the study will be recorded on printed or electronic CRF unless transmitted to the sponsor or designee electronically (eg, laboratory data). The investigator is responsible for verifying that data entries are accurate and correct by physically or electronic... | [] |
NCT05498701 | 10.1.7 | Source Documents | 10.1.7. Source Documents Source documents provide evidence for the existence of the participant and substantiate the integrity of the data collected. Source documents are filed at the investigator site. Data reported on the CRF or entered in the eCRF that are from source documents must be consistent with the source doc... | [] |
NCT05498701 | 10.1.8 | Study and Site Start and Closure | 10.1.8. Study and Site Start and Closure The study start date is the date on which the clinical study will be open for recruitment of participants. The first act of recruitment is the date of the first participant's first visit and will be the study start date. The sponsor designee reserves the right to close the study... | [] |
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