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protocol_id stringclasses 263 values	section_number stringlengths 1 12	title stringlengths 1 1.88k	content stringlengths 0 866k	merged_titles listlengths 0 491
NCT03667690	12.7	Adverse Events of Special Interest	12.7 Adverse Events of Special Interest In addition to SAEs, the following are considered AESIs and should be promptly reported to the Sponsor within 24 hours of awareness by recording the information in the AE eCRF even if the nature of the AE is deemed non-serious according to the usual regulatory criteria. Entry of ...	[]
NCT03667690	12.7.1	Intravenous Infusion Intolerability	12.7.1 Intravenous Infusion Intolerability Events that, in the opinion of the Investigator, may represent intolerance of the IV infusion of study drug. In general, these events would be temporally associated with the IV infusion of the Sponsor's study drug.	[]
NCT03667690	12.7.2	Phototoxicity	12.7.2 Phototoxicity Due to results from a nonclinical phototoxicity study in rats and a Phase 1 clinical trial indicating mild photosensitivity with rezafungin use, subjects should be advised to avoid sun and other UV light exposure without adequate protection. Investigators should report any AE potentially related to...	[]
NCT03667690	12.7.3	Ataxia, Neuropathy, and Tremors	12.7.3 Ataxia, Neuropathy, and Tremors In a rezafungin 3-month toxicity study in monkeys, there were observations of tremors, and histology with Schwann cell hypertrophy/hyperplasia (reversible) and phospholipidosis in the dorsal root ganglia first appearing at week 6 of dosing and at 11-fold the exposure for the dosin...	[]
NCT03667690	12.8	Adverse Event Management	12.8 Adverse Event Management The Investigator should employ best medical judgement in determining how to manage AEs, which may represent intolerability or toxicity to the study drug. Questions regarding AE management should be directed to the Medical Monitor.	[]
NCT03667690	12.9	Risks for Women of Childbearing Potential or During Pregnancy	12.9 Risks for Women of Childbearing Potential or During Pregnancy The risks of Rezafungin for Injection in pregnant or lactating women are unknown. Pregnant and lactating female subjects are excluded from this study. Subjects must be instructed to inform the Investigator immediately if they or their partner becomes pr...	[]
NCT03667690	12.10	Risks for Males of Childbearing Potential	12.10 Risks for Males of Childbearing Potential Recent results from a nonclinical rat fertility study indicated adverse effects on sperm morphology and motility without interference with reproduction were seen at 5.4 times, but not at 2.5 times, the exposure of rezafungin in this study. The risks for rezafungin effects...	[]
NCT03667690	13.0	STATISTICAL METHODS	13.0 STATISTICAL METHODS A Statistical Analysis Plan (SAP) will be prepared and finalized prior to database lock. Any changes to the SAP after it has been signed and prior to the final database lock will be documented in an addendum to the SAP. Any deviations from the final SAP/addendum will be described and justified ...	[]
NCT03667690	13.1	Analysis Populations	13.1 Analysis Populations The analysis populations are defined for this study as follows: - The intent-to-treat (ITT) population will include all randomized subjects, regardless of whether the subject receives study drug. - The Safety population will include all subjects who received any amount of study drug. - The mIT...	[]
NCT03667690	13.2	Subject Characteristics	13.2 Subject Characteristics Demographics (including age, race, and sex), diagnosis at randomization (candidemia and/or invasive candidiasis), diagnosis methodology(blood culture/rapid IVD and culture specimen obtained from a normally sterile site), ANC at randomization (<500 cells/µL and ≥500 cells/µL), medical histor...	[]
NCT03667690	13.3	Study Drug Exposure	13.3 Study Drug Exposure Descriptive statistics for the duration of study drug therapy (IV and oral, and separately for IV therapy and oral therapy) will be summarized by treatment group for the mITT and Safety populations. The number and percentage of subjects with 1–7, 8–14, 15–28, and >28 days of exposure will be pr...	[]
NCT03667690	13.4	Efficacy Analyses	13.4 Efficacy Analyses For efficacy analyses, subject data will be analyzed in the treatment group to which the subject was randomized.	[]
NCT03667690	13.4.1	Primary Efficacy Analyses for the FDA	13.4.1 Primary Efficacy Analyses for the FDA The primary efficacy outcome for the FDA is ACM at Day 30 (-2 days). The addendum to ICH E9 introduces the concept of an estimand which translates the trial objective into a precise definition of the treatment effect that is to be estimated. The description of the estimand i...	[]
NCT03667690	13.4.1.1	Additional Analyses of the FDA Primary Efficacy Outcome	13.4.1.1 Additional Analyses of the FDA Primary Efficacy Outcome To control the overall alpha level, superiority of rezafungin for ACM at Day 30 will be tested in the following order: - If NI is declared for ACM at Day 30 in the mITT population and the rate of ACM at Day 30 in the rezafungin treatment group is lower th...	[]
NCT03667690	13.4.2	Primary Efficacy Analyses for the EMA	13.4.2 Primary Efficacy Analyses for the EMA The primary efficacy outcome for the EMA is global cure at Day 14 (±1 day) based on the DRCs determination. Global response is a composite estimand and ICEs are incorporated into the Protocol Amendment 5 Confidential Page 120 of 156 Cidara Therapeutics, Inc. Protocol CD101....	[ "Cidara Therapeutics, Inc. Protocol CD101.IV.3.05 A5 Rezafungin for Injection", "Where:" ]
NCT03667690	13.4.3	Secondary Efficacy Analyses	13.4.3 Secondary Efficacy Analyses All-cause mortality at Day 30 (-2 days) is a secondary outcome for the EMA and global cure at Day 14 (±1 day) as confirmed by DRC is a secondary outcome for the FDA. The secondary efficacy outcomes are global cure (as confirmed by the DRC), mycological response, radiological response ...	[]
NCT03667690	13.4.4	Additional Efficacy Analyses	13.4.4 Additional Efficacy Analyses The number and percentage of subjects with resolution of all systemic signs attributable at baseline to candidemia and/or invasive candidiasis at Day 5, Day 14 (±1 day), Day 30 (-2 days) and Follow-up (Days 52–59) will be presented by treatment group in the mITT population. The numbe...	[]
NCT03667690	13.5	Safety Analyses	13.5 Safety Analyses All safety analyses will be conducted in the Safety population and will be summarized by study drug actually received. A TEAE is defined as an AE that occurs during or after the first dose of study drug up through the Follow-up visit (Days 52–59). An overall summary of AEs will be provided by treat...	[]
NCT03667690	13.6	Health Economics Outcome Research	13.6 Health Economics Outcome Research Descriptive statistics of the total length of hospital stay and the total length of ICU stay will be provided by treatment group.	[]
NCT03667690	13.7	Pharmacokinetic Analyses	13.7 Pharmacokinetic Analyses Samples from this study may be included in a population PK analysis, which will be reported separately. In addition, rezafungin plasma protein binding and albumin concentrations will be determined from pre-dose plasma samples from subjects enrolled prior to amendment 5, and reported separa...	[]
NCT03667690	13.8	Determination of Study Sample Size	13.8 Determination of Study Sample Size For the EMA endpoint of global cure (confirmed by the DRC), using a 20% NI margin, one-sided alpha of 0.025, 80% power, 1:1 randomization, a global cure rate of 70% in both the Rezafungin for Injection and caspofungin groups, and the sample size methodology based on a continuity ...	[]
NCT03667690	13.9	Data and Safety Monitoring Board	13.9 Data and Safety Monitoring Board An independent external DSMB will be established to review safety data. The DSMB will review safety data when approximately 50% of subjects are randomized and as required for AEs of special interest as provided in the DSMB Charter. The DSMB will be comprised of clinicians and a sta...	[]
NCT03667690	13.10	Handling of Dropouts and Missing, Unused, and Spurious Data	13.10 Handling of Dropouts and Missing, Unused, and Spurious Data Every effort will be made to collect all data at specified times. For primary outcome measure (FDA), if the subject's survival status is unknown at Day 30, the subject will be assumed deceased. A sensitivity analysis of the primary outcome (FDA) will be ...	[]
NCT03667690	13.11	Subject Disposition	13.11 Subject Disposition Enrollment and discontinuations from the study and from study drug will be summarized by treatment group, including the reasons for discontinuation from the study and from study drug. Subjects who prematurely discontinue the study or study drug due to COVID-19 will be summarized.	[]
NCT03667690	13.12	Deviation Reporting	13.12 Deviation Reporting Protocol deviations will be summarized by treatment group. Protocol deviations are defined as any variation from the protocol, including enrollment of a subject who did not meet all inclusion and exclusion criteria and failure to perform the assessments and procedures within the required time ...	[]
NCT03667690	13.13	Impact of the COVID-19 Pandemic on Analyses	13.13 Impact of the COVID-19 Pandemic on Analyses The COVID-19 pandemic may impact study participants' ability to return to the clinic possibly resulting in premature discontinuation of study drug, premature discontinuation of the study, Protocol Amendment 5 Confidential Page 125 of 156 Cidara Therapeutics, Inc. Proto...	[ "Cidara Therapeutics, Inc. Protocol CD101.IV.3.05 A5 Rezafungin for Injection" ]
NCT03667690	14.0	INVESTIGATOR REQUIREMENTS	14.0 INVESTIGATOR REQUIREMENTS	[]
NCT03667690	14.1	Protocol Adherence	14.1 Protocol Adherence The Investigator must adhere to the protocol as detailed in this document and agree that the Sponsor must approve any change to the protocol before seeking approval from the IRB/IEC. The Investigator will be responsible for enrolling only those subjects who have met the protocol inclusion and ex...	[]
NCT03667690	14.2	Electronic Case Report Forms	14.2 Electronic Case Report Forms The contract research organization will make the eCRF accessible to authorized personnel over the internet from an Electronic Data Capture (EDC) system used for the recording of study data as specified by this protocol. All eCRFs must be completed by trained study personnel. The Invest...	[]
NCT03667690	14.3	Source Document Maintenance	14.3 Source Document Maintenance Source documents are defined as documentation related to original observations and activities of a clinical investigation. Source documents may include, but are not limited to, study progress notes, study- or subject-specific e-mail correspondence, computer printouts, laboratory data, a...	[]
NCT03667690	14.4	Study Monitoring Requirements	14.4 Study Monitoring Requirements An authorized Sponsor representative will conduct site visits to inspect study data, subjects' medical records, and eCRFs in accordance with ICH guidelines, GCPs, and the foreign regulations and guidelines, as applicable. A monitor will be utilized for monitoring ongoing drug accounta...	[]
NCT03667690	14.5	Study Completion	14.5 Study Completion The Sponsor requires the following data and materials before a study can be considered complete or terminated: - Laboratory findings, clinical data, and all special test results from Screening throughout the study until the Follow-up visit (Day 52-59) - eCRFs (including data queries) properly comp...	[]
NCT03667690	15.0	QUALITY CONTROL AND QUALITY ASSURANCE	15.0 QUALITY CONTROL AND QUALITY ASSURANCE Written Standard Operating Procedures (SOPs) will be followed to ensure that the study is conducted, and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirements. Quality control will be applied to...	[]
NCT03667690	16.0	PROTECTION OF HUMAN SUBJECTS	16.0 PROTECTION OF HUMAN SUBJECTS This study will be conducted in compliance with the ICH Technical Requirements for Registration of Pharmaceuticals for Human Use E6 GCP: Consolidated Guidelines, the ethical principles of the Declaration of Helsinki, FDA GCP guidelines, and any additional national or IRB/IEC-required p...	[]
NCT03667690	16.1	Informed Consent	16.1 Informed Consent This study will be conducted in compliance with ICH E6 GCP: Consolidated Guidelines pertaining to informed consent. Subjects will give written consent to participate in the study at the first visit, prior to initiation of any study-related procedures, after having been informed about the nature an...	[]
NCT03667690	16.2	IRB/IEC Approval	16.2 IRB/IEC Approval This protocol, the ICF, and all relevant supporting data must be submitted to the IRB/IEC for approval. The protocol, ICF, and any advertisement used to recruit study subjects must be approved by the IRB/IEC. Approval by the IRB/IEC of the protocol and ICF must be obtained before the study may be ...	[]
NCT03667690	17.0	DATA HANDLING AND RECORD KEEPING	17.0 DATA HANDLING AND RECORD KEEPING Training sessions, regular monitoring of Investigators by Sponsor-designated personnel, instruction manuals, data verification, crosschecking, and data audits will be performed to ensure quality of all study data. Investigator meetings will be performed to prepare Investigators and...	[]
NCT03667690	17.1	Direct Access to Source Data/Documentation	17.1 Direct Access to Source Data/Documentation The Investigator agrees by his/her participation that the results of this study may be used for submission to national or international registration. If required, these authorities will be provided with the name of the Investigator and his or her address, qualifications, ...	[]
NCT03667690	17.2	Study Drug Accountability	17.2 Study Drug Accountability All supplies of Rezafungin for Injection, oral fluconazole, placebo for Rezafungin for Injection, placebo for caspofungin IV, and placebo for oral step-down therapy required for completion of this study will be provided by the Sponsor. It is the responsibility of the unblinded Pharmacy st...	[]
NCT03667690	17.3	Retention of Records	17.3 Retention of Records Essential documents should be retained until at least 2 years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region or at least 2 years have elapsed since the formal discontinuation of clinical...	[]
NCT03667690	18.0	FINANCING AND INSURANCE	18.0 FINANCING AND INSURANCE The financing and insurance for this study are outlined in the Clinical Trial Agreement.	[]
NCT03667690	19.0	PUBLICATION POLICY	19.0 PUBLICATION POLICY The data generated in this clinical study are the exclusive property of the Sponsor and are confidential. Authorship on any publication of the results from this study will be based on contributions to study design, enrollment, data analysis, and interpretation of results. Protocol Amendment 5 Co...	[]
NCT03667690	20.0	REFERENCES	20.0 REFERENCES Alexander BD, Johnson MD, Pfeiffer CD, Jiménez-Ortigosa C, Catania J, Booker R, Castanheira M, Messer SA, Perlin DS, Pfaller MA. Increasing echinocandin resistance in Candida glabrata: clinical failure correlates with presence of FKS mutations and elevated minimum inhibitory concentrations. Clin Infect ...	[ "Cidara Therapeutics, Inc. Protocol CD101.IV.3.05 A5 Rezafungin for Injection" ]
NCT03667690	21.0	APPENDICES	21.0 APPENDICES APPENDIX 1: CLINICAL AND LABORATORY STANDARDS INSTITUTE (CLSI) AND EUROPEAN COMMITTEE ON ANTIMICROBIAL SUSCEPTIBILITY TESTING (EUCAST) BREAKPOINTS FOR CANDIDA SPP. The following table provides susceptibility breakpoints for both Clinical and Laboratory Standards Institute (CLSI) and European Committee o...	[ "Cidara Therapeutics, Inc. Protocol CD101.IV.3.05 A5 Rezafungin for Injection", "APPENDIX 2: CREATININE CLEARANCE", "APPENDIX 3: LABORATORY TESTS", "APPENDIX 4: CHILD-PUGH SCORE", "APPENDIX 6: GLASGOW COMA SCORE", "APPENDIX 7: POTENTIAL DRUG INTERACTIONS, WARNINGS, AND PRECAUTIONS", "Appendix 7A: Caspof...
NCT03671434	1.0	Objectives	1.0 Objectives	[]
NCT03671434	1.1	Study Objectives	1.1 Study Objectives Describe the purpose, specific aims or objectives. State the hypotheses to be tested. This mixed-methods study will evaluate the impact of the Research-to-Policy Collaboration (RPC) model on the use of scientific research in federal policymaking. Human Subjects research will be carried out to asses...	[]
NCT03671434	1.2	Primary Study Endpoints	1.2 Primary Study Endpoints State the primary endpoints to be measured in the study. Clinical trials typically have a primary objective or endpoint. Additional objectives and endpoints are secondary. The endpoints (or outcomes), determined for each study subject, are the quantitative measurements required by the object...	[]
NCT03671434	1.3	Secondary Study Endpoints	1.3 Secondary Study Endpoints State the secondary endpoints to be measured in the study. Experiences collaborating with public official will be assessed among participants in the RPC intervention (experimental) condition. Aspects of these collaboration experiences that will be measured include satisfaction, perceived v...	[]
NCT03671434	2.0	Background	2.0 Background	[]
NCT03671434	2.1	Scientific Background and Gaps	2.1 Scientific Background and Gaps Describe the scientific background and gaps in current knowledge. The persistent gap between research and policymaking is a multifaceted challenge borne in part out of limited interaction between researchers and public officials. Yet, interaction without adequate preparation for polic...	[]
NCT03671434	2.2	Previous Data	2.2 Previous Data Describe any relevant preliminary data. N/A	[]
NCT03671434	2.3	Study Rationale	2.3 Study Rationale Provide the scientific rationale for the research. The RPC model is based on a growing literature around the use of scientific evidence in policymaking, which emphasizes the need to cultivate positive interactions and collaborations between researchers and public officials. A prominent facilitator f...	[]
NCT03671434	3.0	Inclusion and Exclusion Criteria	3.0 Inclusion and Exclusion Criteria Create a numbered list below in sections 3.1 and 3.2 of criteria subjects must meet to be eligible for study enrollment (e.g., age, gender, diagnosis, etc.). Indicate specifically whether you will include any of the following vulnerable populations: (You may not include members of t...	[ "• Adults unable to consent", "• Pregnant women", "• Prisoners", "• Neonates of uncertain viability or non-viable neonates" ]
NCT03671434	3.1	Inclusion Criteria	3.1 Inclusion Criteria List the criteria that define who will be included in your study. Researchers who voluntarily enlist in the RPC will be asked to participate in the trial. All participants will be over 18 years old.	[]
NCT03671434	3.2	Exclusion Criteria	3.2 Exclusion Criteria List the criteria that define who will be excluded in your study. None.	[]
NCT03671434	3.3	Early Withdrawal of Subjects	3.3 Early Withdrawal of Subjects	[]
NCT03671434	3.3.1	Criteria for removal from study	3.3.1 Criteria for removal from study Insert subject withdrawal criteria (e.g., safety reasons, failure of subject to adhere to protocol requirements, subject consent withdrawal, disease progression, etc.). Researchers who choose to stop participating in the study or the RPC itself. All study participants can choose to...	[]
NCT03671434	3.3.2	Follow-up for withdrawn subjects	3.3.2 Follow-up for withdrawn subjects Describe when and how to withdraw subjects from the study; the type and timing of the data to be collected for withdrawal of subjects; whether and how subjects are to be replaced; the follow-up for subjects withdrawn from investigational treatment. No follow-up will be conducted w...	[]
NCT03671434	4.0	Recruitment Methods	4.0 Recruitment Methods	[]
NCT03671434	4.1	Identification of subjects	4.1 Identification of subjects Describe the methods that will be used to identify potential subjects or the source of the subjects. If not recruiting subjects directly (e.g., database query for eligible records or samples) state what will be queried, how and by whom. StudyFinder: If you intend to use StudyFinder(http:/...	[]
NCT03671434	4.2	Recruitment process	4.2 Recruitment process Describe how, where and when potential subjects will be recruited (e.g., approaching or providing information to potential subjects for participation in this research study). All researchers who voluntarily sign-up to participate in the RPC will be invited to participate in this study. Researche...	[]
NCT03671434	4.3	Recruitment materials	4.3 Recruitment materials List the materials that will be used to recruit subjects. Add recruitment documents to your study in CATS IRB (http://irb.psu.edu) on the "Consent Forms and Recruitment Materials" page. For advertisements, upload the final copy of printed advertisements. When advertisements are taped for broad...	[]
NCT03671434	4.4	Eligibility/screening of subjects	4.4 Eligibility/screening of subjects If potential subjects will be asked eligibility questions before obtaining informed consent, describe the process. Add the script documents and a list of the eligibility questions that will be used to your study in CATS IRB (http://irb.psu.edu) on the "Consent Forms and Recruitment...	[]
NCT03671434	5.0	Consent Process and Documentation	5.0 Consent Process and Documentation Refer to "SOP: Informed Consent Process for Research (HRP-090)", for information about the process of obtaining informed consent from subjects. HRP-090 can be accessed by clicking the Library link in CATS IRB (http://irb.psu.edu).	[]
NCT03671434	5.1	Consent Process	5.1 Consent Process	[]
NCT03671434	5.1.1	Obtaining Informed Consent	5.1.1 Obtaining Informed Consent	[]
NCT03671434	5.1.1.1	Timing and Location of Consent	5.1.1.1 Timing and Location of Consent Describe where and when the consent process will take place. The study consent form is provided online immediately subsequent to a researcher enlisting in the RPC (which also occurs online) and prior to entering the online survey. RPC participants will then be asked to agree or de...	[]
NCT03671434	5.1.1.2	Coercion or Undue Influence during Consent	5.1.1.2 Coercion or Undue Influence during Consent Describe the steps that will be taken to minimize the possibility of coercion or undue influence in the consent process. The consent form notes that study participation is voluntary and there is an option to decline participating in the study such that researchers may ...	[]
NCT03671434	5.1.2	Waiver or alteration of the informed consent requirement	5.1.2 Waiver or alteration of the informed consent requirement If you are requesting a waiver or alteration of consent (consent will not be obtained, required information will not be disclosed, or the research involves deception), describe the rationale for the request in this section. If the alteration is because of d...	[]
NCT03671434	5.2	Consent Documentation	5.2 Consent Documentation	[]
NCT03671434	5.2.1	Written Documentation of Consent	5.2.1 Written Documentation of Consent Refer to "SOP: Written Documentation of Consent (HRP-091)" for information about the process to document the informed consent process in writing. HRP-091 can be accessed by clicking the Library link in CATS IRB (http://irb.psu.edu). If you will document consent in writing, describ...	[]
NCT03671434	5.2.2	Waiver of Documentation of Consent(Implied consent, Verbal consent, etc.)	5.2.2 Waiver of Documentation of Consent(Implied consent, Verbal consent, etc.) If you will obtain consent (verbal or implied), but not document consent in writing, describe how consent will be obtained. Add the consent script(s) and/or information sheet(s) to your study in CATS IRB (http://irb.psu.edu) on the "Consent...	[]
NCT03671434	5.3	Consent – Other Considerations	5.3 Consent – Other Considerations	[]
NCT03671434	5.3.1	Non-English Speaking Subjects	5.3.1 Non-English Speaking Subjects Indicate what language(s) other than English are understood by prospective subjects or representatives. If subjects who do not speak English will be enrolled, describe the process to ensure that the oral and written information provided to those subjects will be in that language. Ind...	[]
NCT03671434	5.3.2	Cognitively Impaired Adults	5.3.2 Cognitively Impaired Adults Refer to "CHECKLIST: Cognitively Impaired Adults (HRP-417)" for information about research involving cognitively impaired adults as subjects. HRP-417 can be accessed by clicking the Library link in CATS IRB (http://irb.psu.edu).	[]
NCT03671434	5.3.2.1	Capability of Providing Consent	5.3.2.1 Capability of Providing Consent Describe the process to determine whether an individual is capable of consent. RPC participants, and consequently study participants, include high-functioning research faculty, professors, evaluators, and other skilled professionals who will have the capacity to provide consent.	[]
NCT03671434	5.3.2.2	Adults Unable To Consent	5.3.2.2 Adults Unable To Consent Describe whether and how informed consent will be obtained from the legally authorized representative. Describe who will be allowed to provide informed consent. Describe the process used to determine these individual's authority to consent to research. For research conducted in the stat...	[]
NCT03671434	5.3.2.3	Assentof Adults Unable to Consent	5.3.2.3 Assentof Adults Unable to Consent Describe the process for assent of the subjects. Indicate whether assent will be required of all, some or none of the subjects. If some, indicate which subjects will be required to assent and which will not. If assent will not be obtained from some or all subjects, provide an e...	[]
NCT03671434	5.3.3	Subjects who are not yet adults (infants, children, teenagers)	5.3.3 Subjects who are not yet adults (infants, children, teenagers)	[]
NCT03671434	5.3.3.1	Parental Permission	5.3.3.1 Parental Permission Describe whether and how parental permission will be obtained. If permission will be obtained from individuals other than parents, describe who will be allowed to provide permission. Describe the process used to determine these individual's authority to consent to each child's general medica...	[]
NCT03671434	5.3.3.2	Assentof subjects who are not yet adults	5.3.3.2 Assentof subjects who are not yet adults Indicate whether assent will be obtained from all, some, or none of the children. If assent will be obtained from some children, indicate which children will be required to assent. When assent of children is obtained describe whether and how it will be documented. N/A	[]
NCT03671434	6.0	HIPAA Research Authorization and/or Waiver or Alteration of Authorization	6.0 HIPAA Research Authorization and/or Waiver or Alteration of Authorization This section is about the access, use or disclosure of Protected Health Information (PHI). PHI is individually identifiable health information (i.e., health information containing one or more 18 identifiers) that is transmitted or maintained ...	[]
NCT03671434	7.0	Study Design and Procedures	7.0 Study Design and Procedures	[]
NCT03671434	7.1	Study Design	7.1 Study Design Describe and explain the study design. This human subjects research involves a longitudinal randomized controlled trial and depth interviews of researchers who participate in the Research-to-Policy Collaboration (RPC). Researchers are recruited to participate in the RPC. When a researcher voluntarily e...	[]
NCT03671434	7.2	Study Procedures	7.2 Study Procedures Provide a description of all research procedures being performed and when they are being performed (broken out by visit, if applicable), including procedures being performed to monitor subjects for safety or minimize risks. Include any long-term follow-up procedures and data collection, if applicab...	[]
NCT03671434	7.2.1	EXAMPLE: Visit 1 or Day 1 or Pre-test, etc.(format accordingly)	7.2.1 EXAMPLE: Visit 1 or Day 1 or Pre-test, etc.(format accordingly) Provide a description as defined above and format accordingly. Online surveys using Qualtrics will be administered at the time when researchers sign-up to participate in the RPC. Survey instruments are provided as a supporting document. The survey as...	[]
NCT03671434	7.2.2	EXAMPLE: Visit 2 or Day 2 or Post-test, etc. (format accordingly)	7.2.2 EXAMPLE: Visit 2 or Day 2 or Post-test, etc. (format accordingly) Provide a description as defined above and format accordingly. The same survey protocol as used in the pre-test will be administered approximately every three months for about one year: (2) Subsequent to training, (3) Subsequent to policy engagemen...	[]
NCT03671434	7.3	Duration of Participation	7.3 Duration of Participation Describe the duration of an individual subject's participation in the study. Study participation lasts for up to two years or until the participant opts-out of the study.	[]
NCT03671434	8.0	Subject Numbers and Statistical Plan	8.0 Subject Numbers and Statistical Plan	[]
NCT03671434	8.1	Number of Subjects	8.1 Number of Subjects Indicate the total number of subjects to be accrued. If applicable, distinguish between the number of subjects who are expected to be enrolled and screened, and the number of subjects needed to complete the research procedures (i.e., numbers of subjects excluding screen failures.) We aim to enrol...	[]
NCT03671434	8.2	Sample size determination	8.2 Sample size determination If applicable, provide a justification of the sample size outlined in section 8.1 – to include reflections on, or calculations of, the power of the study. Statistical analyses are all powered at least at a 90% level to detect effect sizes of 0.2 or greater (power analysis conducted with Op...	[]
NCT03671434	8.3	Statistical methods	8.3 Statistical methods Describe the statistical methods (or non-statistical methods of analysis) that will be employed. Surveys data will be analysed longitudinally by modelling change across 4 time points—including repeated measures and multilevel growth curve models (MLM) using MPlus. Missing data will be handled wi...	[]
NCT03671434	9.0	Confidentiality, Privacy and Data Management	9.0 Confidentiality, Privacy and Data Management For research being conducted at Penn State Hershey or by Penn State Hershey researchers only, the research data security and integrity plan is submitted using "HRP-598 – Research Data Plan Review Form Application Supplement", which is available in the Library in CATS IRB...	[]
NCT03671434	9.1	Confidentiality	9.1 Confidentiality	[]
NCT03671434	9.1.1	Identifiers associated with data and/or specimens	9.1.1 Identifiers associated with data and/or specimens List the identifiers that will be included or associated with the data and/or specimens in any way (e.g., names, addresses, telephone/fax numbers, email addresses, dates (date of birth, admission/discharge dates, etc.), medical record numbers, social security numb...	[]
NCT03671434	9.1.1.1	Use of Codes, Master List	9.1.1.1 Use of Codes, Master List If identifiers will be associated with the data and/or specimens (as indicated in section 9.1.1 above), describe whether a master record or list containing a code (i.e., code number, pseudonyms) will be used to separate the data collected from identifiable information, where that maste...	[]
NCT03671434	9.1.2	Storage of Data and/or Specimens	9.1.2 Storage of Data and/or Specimens Describe where, how and for how long the data (hardcopy (paper) and/or electronic data) and/or specimens will be stored. NOTE: Data can include paper files, data on the internet or websites, computer files, audio/video files, photographs, etc. and should be considered in the respo...	[]
NCT03671434	9.1.3	Access to Data and/or Specimens	9.1.3 Access to Data and/or Specimens Identify who will have access to the data and/or specimens. This information should not conflict with information provided in section 9.1.1.1 regarding who has access to identifiable information, if applicable. Max Crowley, Taylor Scott, and the research team will have access to st...	[]
NCT03671434	9.1.4	Transferring Data and/or Specimens	9.1.4 Transferring Data and/or Specimens If the data and/or specimens will be transferred to and/or from outside collaborators, identify the collaborator to whom the data and/or specimens will be transferred and how the data and/or specimens will be transferred. This information should not conflict with information pro...	[]
NCT03671434	9.2	Subject Privacy	9.2 Subject Privacy This section must address subject privacy and NOT data confidentiality. Indicate how the research team is permitted to access any sources of information about the subjects. Describe the steps that will be taken to protect subjects' privacy interests. "Privacy interest" refers to a person's desire to...	[]

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