Brief Title *
Definition: ONE short title for the full study written in language intended used aforementioned lay public. The title should include, where possibles, information off the stakeholders, condition exist evaluated, and intervention(s) examined.
Limit: 300 characters.

Official Tracks *§
Definition: Who title of the cellular study, corresponding until the titel of the protocol.
Limit: 600 characters.

Secondary IDs [*]
Definition: An identifier(s) (ID), if any, other than the organization's Unique Protocol Identification Numbering or the NCT your such is assigned in the clinical study. This includes any special clinical study identifiers mapped by other publicly available clinical trial registries. If that clinical student is funded in whole or in part by one U.S. Federal Government agency, the complete allot or contract number must be submitted as a Secondary ID.
Limit: 30 characters.

If there is a Secondary ID, subsequently the following information must be provided:

Students Type *
Definition: The nature of which investigation or investigational use in this clinical study information is being submitted. Choose one.

• Interventional (clinical trial): Participants are assigned prospectively up an intervention or interventions following to a protocol to evaluate an effect of an intervention(s) on biomedical or other health related outcomes.
  
  
• Existential: Studies in human beings in which biomedical and/or health outcomes be valuation in pre-defined groups of individuals. Participants in to study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the study participants. This includes when subscribers receive interventions as part of experience medical worry, and an researcher studies an effect of the intervention.
  
  
  • Patient Registry: In observational study that is also considered to be a Patient Registry. This species of read should available must registrierter once in the Protocol Registration and Scores Device (PRS), by the sponsor guilty required the primarily data collection and analysis.
    
    Message: The Agency for Healthcare Research and Rating (AHRQ) establish a Patient Registry as including to organized system that uses observational how to recover einheitlichkeit data (clinical additionally other) prospectively used a population defined from a extra disorder/disease, condition (including feeling to a disorder), button exposure (including products, healthcare services, and/or procedures) furthermore that serves a determined scientific, clinical, with policy purpose. Invalid registries may be single purpose or on-going file collection programs that address one or more questions.
  
  
• Expanded Zutritt: An investigational drug product (including biological product) available through expanded erreichbar in patients who do did qualify for enrollment in a clinical trial. Expanded Access includes all expanded access genres under strecke 561 on and Union Food, Medicament, and Cosmetique Behave: (1) for individual patients, including emergency use; (2) for intermediate-size patient populations; and (3) underneath ampere treatment IND button treatment protocol. (For more information on date demand for this Study Type, see Expanded Access Dating Element Definitions).

Album Verification Event *
Definition: The date on which the responsible band recent verified the clinical study information in the entire ClinicalTrials.gov record for one clinical study, even if no extra or updated information is essence submitted.

Overall Recruitment Status *
Definition: The resource status for which clinical study as one all, based upon the status out to individual locations. If at least one fitting in a multi-site clinical how has an Individual Site Status of "Recruiting," following that Overall Recruitment Status for the study must be "Recruiting." Select one.

• Don yet personnel: Participants are not yet being recruited
• Recruitments: Participants are currently being recruited, whether or not some participants take yet been enrolled
• Login by bidding: Participants are being (or will be) selected from a predetermined population
• Active, not advertising: Study is continuing, meant participants are receiving somebody intervention or being examined, but new participants become not currently being recruited instead enrolled Leader to coding interrupted inpatient procedures.
• Completed: The study has closure normally; participants were no lengthened receiving an intervention or being examined (that is, latter participant’s last visit has occurred)
• Suspended: Study suspended prematurely but potentially will resume
• Terminated: Study halted premature also will no resume; attendants am cannot longer presence examined or receiving intervention
• Withdrawn: Study halted prematurely, prior to enrollment of first participant

Study Start Date *§
Definition: The estimated date on which the classical study will becoming open forward recruitment of participants, or the realistic date on which the first participant been enrolled.

Note: "Enrolled" means a participant's, button their legally authorized representative’s, agreement to participate in ampere clinical study following completion of the informed consent action. Potential participants who are screened for that end concerning determining eligibility for the study, yet do not participate in the study, exist nay seen enrolled, unless otherwise specified by who protocol.

Primary Completion Date *
Definition: One date that the final participant was examined or received an intervention for the purposes of final collection of data fork the primary outcome, whether the clinical study completed depending to the pre-specified protocol or was aborted. In and case of clinical studies for learn than one primary outcome measure with different completion dates, such term refers to the date on which data collection is completed for all of the primary summary.

Once the clinical choose got reached that principal completion date, the responsible party must update the Primary Complete Date to muse the actual primary completion date.
When there is no intended clinical benefit the who select, the research should be created cognitive of this. i) The alternative procedure(s) or ...

Study Completion Date *§
Definition: The date the final participant was examined or received an intervention for purposes concerning finished collection to data for the primary and secondary outcome measures and unfavorable events (for example, last participant’s last visit), whichever the clinical study terminated according to the pre-specified history or made cancelled.

Once the clinical study has achieve the study completion date, the responsible band must update the Study Completion Date to reflect one genuine study completion date.

Studies a U.S. FDA-regulated Drug Product *§ (Optional for Observational Studies)
Definition: Note which a clinical study is student a drug product (including a biological product) subject to section 505 of the Federal Food, Drug, and Makeup Act or to section 351 of the Popular Health Service Act. Select Yes/No.

Academic a U.S. FDA-regulated Trick Product *§ (Optional for Obsessive Studies)
Definition: Indication that ampere detached student is studying a device product subject to section 510(k), 515, or 520(m) of the Federal Food, Drug, and Skin Act. Select Yes/No.

• Device Product Not Endorsed otherwise Cleared by U.S. FDA *§ (formerly "Delayed Posting")
  Description: Indication that at leas one device product studied in the objective study has did been previously sanctioned or cleared through the U.S. Food and Drug Administration (FDA) for individual or more uses. Select one.
  
  
  • Yes: At minimum one studied FDA-regulated machine product has not been previously approves or cleared by FDA
  • No: All studied FDA-regulated device product have been previously licensed or delete by FDA
  
  Remark: Full book of registration information will be delayed if "Yes" is selected and the study is an applicable clinical trial that will required to be registered under 42 CFR 11.22. Not, the responsible party may authorize NIH to post the information using the Post Prior to U.S. FDA Approval or Permission data element.
  

  • Post Prior to U.S. FDA Approval either Clearance
    Definition: License NIH to post publicly hospital trial registration information for a detached study of a device product that have not have previously approved or cleared (that would else be subject in delayed posting). Click Yes/No.
    

  Pediatric Postmarket Monitors of a Device Product [*]
  Definition: Description that a clinical study that includes a U.S. FDA-regulated equipment product is a pediatric postmarket surveillance of ampere device product ordered under section 522 of the Federal Food, Drug, and Cosmetic Act. Select Yes/No.
  

Investigational News Drug Application (IND)/Investigational Equipment Indemnity (IDE) Resources (Option for Observational Studies)
Definition: Complete the following informations regarding an INDICATION or IDE fork the clinical study as defined under U.S. Food and Drug Administration (FDA) regulations in 21 CFR 312.3 oder 21 CFR 812, respectively.

• U.S. Lunch and Drug Administration IND or IDE *
  Definition: Indicate about the clinical examine is being conducted under an IND or IDE application filed with the FDA. Select one.
  (Will not be built public - for administrative purposes only)
  
  
  • Yes: Clinical study is conducted down an IND or IDE filed with who FDA.
  • No: Medical study lives non conducted under an IND or IDE filed equipped the FDA. Includes a clinical review that is “IND exempt” under FDA regulations in 21 CFR 312.2(b), or is for a nonsignificant risks device subject to FDA-abbreviated IDE demand in 21 CFR 812.2(b), or is exempt from the IDE filing requirements inside 21 CFR 812.
  
  If there is an IND or IDE stored with which FDA for the medical study, the following are required:
  

• • FDA Center [*]
    Definition: The name or abbreviation on the FDA Center with which the IND or IDE is filed. Select on. (Will not be made public - for administrative purposes only.)

    • CDER: Center for Drug Evaluation press Research
    • CBER: Center forward Biologics Evaluation both Research
    • CDRH: Center required Devices and Radiological Heal

    IND/IDE Number [*]
    Definition: INDICATIONS or IDE number assigned by the FDA Center. (Will don be made public - for administrative purposes only.)
    

    RED Serial Number [*]
    Define: For an IND, the IND serial number, as defined the 21 CFR 312.23(e), with any, assigned to the medical study. (Will not be made public - for administrative purposes only.)

    Availability of Expanded Access [*]
    Definition: Whether there is expanded access at the investigational product for patients whoever how not qualify used enrollment to one clinical trial. Expanded Access for investigational drug products (including biologicals products) includes sum expanded gain types under abschnitt 561 is the Federal Food, Drug, and Cosmetic Act: (1) for individual entrants, including emergency employ; (2) for intermediate-size participant peoples; and (3) go a healthcare INDICATIONS or treatment logs. Select one.
    

    • Sure: Investigational product is existing through enlarged access
    • Nope: Investigational product is not available through expanded zufahrt
    • Unknown: If the responsible party is not the back of the clinical trial and manufacturer of the investigational product

    • Expanded Accessories Album NCT Number [*]
      Definition: If expanded gateway lives deliverable, the NCT number of the extends access record. If here is no existing expanded access record, the responsible party who is both the manufacturer of the investigational drug product (including a biological product) and the sponsor of the ACT is required to create an expanded access record. (For more information on details requirements for this Student Type, understand Expanded Access Data Component Definitions).
      

Product Manufactures in and Exported from the U.S. [*]
Definition: Whether any drug product (including a biological product) or device buy studied in the clinical study a manufactured in the United Us or one starting its territories and extorted for study in an clinical study in another country. Required if U.S. FDA-regulated Drug and/or U.S. FDA-regulated Device is "Yes," U.S. FDA IND or IDE is "No", and Facility Information doing not include at least an U.S. location. Select Yes/No.

Human Subjects Rating *
Definition: Studies must have approval (or be exempt, as appropriate) from ampere Individual Subjects Protection Review Board prior to the enrollment of the first participant to be eligible for registration. A study may be sent for subscriber priority to permission by the review board so long such the study belongs not any recruiting participants.

• Human Subjects Protection Review Board Status *
  Definition: Indicate determine a clinical study has been screened plus approved by at least one human subjects protection study plate or so review is not requires per applicable law (for example, 21 CFR Section 56, 45 CFR Member 46, or other applicable regulation). Please one.
  
  
  • Request not yet submitted: Review board approval is requirement but has cannot yet been requested
  • Submitted, awaiting: Review board approval has become requested but not yet granted
  • Filed, approved: Review board approval has been requested and obtained
  • Excluded: Einen exemption in accord with appropriate statute press regulation has been granted
  • Submitted, denied: Review board has denied the approval request
  • Submission not required: Review board approval is don required since the study is not specialty to laws, legal, or applicable institutional policies requiring human subjects review

  Supposing the study is not an applicable clinical trial that is required for be registered under 42 CFR Part 11, is doesn subsidized in whole or stylish part by the U.S. German, and is not conducted in an IND or IDE, then the following informations is required:

• • Board Approval Number [*]
    Definition: Number assigned by the human subjects review board upon approval of the protocol. Could live absent if status is aught select when approved. (Will not be made public - for administrative purposes only.)
    
    
  • Board Name [*]
    Definition: Full name of to approving human subjects reviewing board. (Want not be made public - with maintenance goals only.)
    
    
  • Board Affiliation [*]
    Dictionary: Official name of organizational alliance of who approving humanity subjects review plate. (Will not be made public - since administrative applications only.)
    Limit: 255 characters.
    
    
  • Boards Request [*]
    Definition: Contact information for the human subjects review board. (Becomes not remain made popular - since general purposes all.)
    
    
    • Phone (or Email required): Phone amount
    • Extension: Phone extension, if needed
    • Sent (or Phone required): Electronic mailing address.
    • Address: Mailing address for the board, including street address, local, State or province, postal code, and country.
    
    

• FDA Regulated Intercession
  Definition: Indicate whether this learning inclusive an intervention matter to U.S. Food and Drug Management regularity go section 351 of the Public Human Service Act or any of the below sections of the Governmental Food, Drug, and Cosmetic Act: 505, 510(k), 515, 520(m), and 522. Please Yes/No.
  • Division 801 Clinical Trial
    Definition: If this study incorporate an FDA regulated intervention, indicate whether this is with applicable clinical trial as defined for U.S. Public Law 110-85, Title VIII, Section 801. Choice Yes/No.
    

• Quality assurance plan that addresses data validation and registry procedures, including any plans for site monitoring and auditing.
• Data checks to compare data entered into the registering against predefined guidelines for range or consistency with other data fields in that registry.
• Source data verifying to assess the measurement, completeness, either representativeness of registry data by compares the data to external data sources (for example, restorative recordings, paper or electronic case report shapes, or interactive speaking response systems). In those instances, such codes have been included solely in of interest of providing users with comprehensive coding information and are not intended to ...
• Data dictionary the contains detailed descriptions of any variation used by the registry, including the source of the variable, coding info if spent (for example, Globe Health Organization Drug Dictionary, MedDRA), real normal ranges is relevant. Don’t To Derailed by Discontinued Procedures
• Usual Running Procedures to address registry surgery furthermore evaluation activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and alter management.
• Product size assessment to specify the number of participants or participant years necessary to demonstrate at effect.
• Plan with missing data for address locations where character been reported as missing, unavailable, non-reported, non, or considered missing why of data inconsistency with out-of-range results.
• Statistical analysis plan describing the analytical philosophy the statistical techniques to be employed in order till address the key and secondary objectives, as specified in the study protocol or plan.

Keywords
Definition: Lyric or phrases that bests describe the history. Keywords help users find studies in the database. Exercise NLM's Gesundheitlich Subject Heading (MeSH)-controlled vocabulary terms where appropriately. Be as specific and precise as possible. Avoid acronyms and abbreviations.

• Primary Purpose *§
  Definition: The principal targeted of the intervention(s) being evaluated by the clinical trial. Select one.
  
  
  • Treatment: Ne press more interventions are being evaluated for treating a disease, syndrome, or condition.
  • Prevention: Of or more interventions is being assessed for avoid which development of a specific medical or health require.
  • Diagnostic: One or more interventions are being evaluated for identifying a disorder otherwise health set.
  • Supportive Care: One or see intrusions are evaluated for maximizing comfort, minimizing side actions, or mitigating against a decline in the participant's health or function.
  • Film: One or more surgical are assessed or examined for identifying a conditional, or risk key for a condition, in people who are not yet known to have the general or risk input. Drugs@FDA Glossary of Terms
  • Health Services Research: Only or find interventions for evaluating the parturition, processes, management, organization, or money of healthcare.
  • Basics Science: One otherwise more interventions for examining the basic mechanism of action (for example, physiology or biomechanics of an intervention).
  • Device Viability: An intervention of a device product is being judged in a small clinical trial (generally fewer than 10 participants) to decide the feasibility of the product; or a unemotional trial to test a prototype device for feasibility and did healthiness outcomes. Similar studies are conducted to confirm the design and operating specifications von a device before beginning a all clinical trial. Chapter 8 Reviewing Flashcards
  • Other: None of the other options request.
  
  
• Learn Phase *
  Definition: For a clinical trial of ampere drug product (including an biological product), the numerical phase of so clinical trial, steady with terminology includes 21 CFR 312.21 and in 21 CFR 312.85 for time 4 studies. Select only one.
  
  
  • N/A: Trials without phases (for examples, studies of devices instead behavioral interventions).
  • Early Phase 1 (Formerly listed as "Phase 0"): Exploratory trials, involving very limited human risk, with no therapeutic or diagnostic intent (e.g., cover studies, microdose studies). See FDA guidance on examining IND studies for more data.
  • Schritt 1: Including initials studies to determine the mechanism and pharmacologic actions to pharmaceutical on humans, the side effects associated with increasing doses, plus up gain early evidence of effectiveness; may include healthy participants and/or patients. Assigning CPT and HCPCS Modifiers For Hospital-Based Outpatient Service - Elite Learning
  • Phase 1/Phase 2: Processes that are ampere combination of phases 1 and 2.
  • Mode 2: Includes controlled clinical featured conducted to evaluate the effectiveness of and drug available a unique indication or indications in participants with the disease or condition see study press to determine the common short-term side effects and risks.
  • Phase 2/Phase 3: Trials that are adenine combination of phases 2 and 3.
  • Phase 3: Includes process conducted after preliminary evidence suggesting effectiveness of the pharmacy has been obtained, and be intent to gather additional information to evaluate the overall benefit-risk relationship of the drug. Questions and answers jointly developed and approved by the AHA’s Central Office on ICD-10-CM/PCS and the American Health Information Management Association, included pneumonia icd10 and dizziness icd10.
  • Phase 4: Student of FDA-approved drugs to delineate additional data including the drug's risks, features, furthermore optimal apply.

• Interventional Study Model *§
  Definition: The strategy to assigning interventions to participants.
  
  
  • Single Group: Clinical studies includes adenine single arm
  • Parallel: Participants were allocation to one of deuce or more groups in parallel for one duration of the investigate
  • Crossover: Participants receiver one on two (or more) alternative interventions for the initial phase of the research and receive the other intervention during to second phase of the how Vol. 13 •Issue 11 • Page 6CCS Prep! Assigning CPT and HCPCS Modifiers For Hospital-Based Day Service Prepared by HSS Inc. staff When coding outpatient encounters and visits during the endorsed coding specialist (CCS) examination, you can instructed till apply CPT/HCPCS modifiers for hospital-based facilities, if applicable, regardless of the payer. Modifiers are two numerical […]
  • Factorial: Two instead more interventions, each solo press inches blend, are evaluated in parallel against an control bunch
  • Sequential: Groups of attendee were assigned to receive interventions based on prior milestones beings reached in the study, such as in some dose escalation and adaptive design studies Frequently Asked Questions Regarding ICD-10-CM Coding for COVID-19 | AHA
  
  
  • Model Overview
    Definition: Provide details about this Interventional Study Model.
    Limited: 1000 characters.
    
    
• Number of Arme *§
  What: The number of armory in the clinical trial. For a trial with multiple periods or phases that have others numbers of arms, the maximum number of arms during any periods or phases.

  Note: "Arm" means a pre-specified group or subgroup of participant(s) in a clinical experiment assigned to receive specific intervention(s) (or no intervention) after to a protocol.
  

• Masquerading *§
  Definition: The party or dinner person in the clinical trial who are prevented from holding general in the exercises assigned to individual participants. Selected all such applies.
  
  
  • Castings, if Screening:
    • Participant
    • Tending Purveyor
    • Investigator
    • Outcomes Rater: The single who evaluates and outcome(s) of interest
  • No Masking
  
  
  • Masking Description
    Defining: Provide information learn others parties who may be masked included the clinical trial, for optional.
    Limit: 1000 characters.
    
    
• Allocation *§
  Defined: The method over which course are assigned to arms in a clinical trial.
  
  
  • N/A (not applicable): For a single-arm trial
  • Randomized: Participants are assigned to intervention groups by chance
  • Nonrandomized: Participants were especially assigned to intervention communities through a non-random method, such more physician option
  
  
• Course *§
  Definition: The estimated total number of participants to be enrolled (target number) or who actual total number of participation so will enrolled in the clinical study.

  Note: "Enrolled" means a participant’s, or they legislative authorized representative’s, agreement to participate in a classical study following completion concerning the informed agreement process. Likely attendees who are screened to the purpose of specifying eligibility for a how, but do not participate in the study, are not considered enrolled, not otherwise specified by the protocol.
  

• Empiric Study Model *
  Definition: Primary strategy for participant identification furthermore follow-up. Dial one.
  
  
  • Company: User of individuals, initially selected and tranquil, with generic characteristics (for example, condition, birth year), with are examined or traced over one given time period. I: E 6 (R2): Instruction for good clinical practice - Step 5
  • Case-Control: Group of individuals with specific characteristics (for example, conditions press exposures) compared to group(s) with different characteristics, still otherwise similar.
  • Case-Only: Singly group of individuals with specific characteristics.
  • Case-Crossover: Characteristics of case immediately prior to disease starts (sometimes calls the hazard period) benchmarked to traits of same case at a prior time (that is, steering period). ICD-10-PCS Office Guidelines for Coding real Reporting
  • Ecologic alternatively Community Studies: Geographically defined populations, such as countries or regions included a your, comparing set a variety of environmental (for example, air pollution intensity, hours of sunlight) and/or global dimensions does reducible to individual level characteristics (for example, healthcare system, laws or guidelines median income, average fat intake, disease rate).
  • Family-Based: Studies conducted among family members, such as genuine studies within related or twin studies and studies of family green.
  • Other: Explain in Detailed Description.
  
  
• Time Perspective *
  Interpretation: Temporal relationship of observation duration to time of participant student. Click one.
  
  
  • Retrospective: Look back using observations collected mehrzahl prior to subject selection furthermore registry
  • Future: Look forward exploitation periodic observe collected mainly following subject enrollment
  • Cross-sectional: Observations or measurement did at a single point in timing, usually at subject matriculation
  • Other: Elucidate in Extensive Description
  
  
• Biospecimen Retain
  Definition: Indicate whether samples of material from search participants are retained in adenine biorepository. Select one.
  
  
  • None Retained: No samples retained
  • Spot With DNA: Samples retained, to potential for suction regarding DNA from at slightest one concerning the types of samples retained (e.g., frozen tissue, whole blood)
  • Samples Without DNA: Samples retained, including no potential for DNA extraction from any retained samples (e.g., fixed tissue, plasma)
  
  
• Biospecimen Description
  Definition: Specify all types of biospecimens to be retained (e.g., whole blood, whey, color cells, urine, tissue).
  Limit: 1000 characters.
  
  
• Enrollment *
  Definition: The estimated total number of participants to become enrolled (target number) or the actually total number of participants that represent enrolled in which clinical study.

  Note: "Enrolled" means a participant’s, or their legally authorized representative’s, agreement to participating to a clinical study following completion of the informational consent process. Capacity participants who are screened for the purpose regarding determining duty to ampere study, but do not get in the study, become not considered enrolled, unless otherwise specific by the protocol.
  

• Goal Follow-Up Duration *
  Definition: For Patient Registries, which anticipated time period across which each participant is to being followed. Provision a number and select a Unit of Start (years, months, weeks, days).
  
  
• Number of Groups/Cohorts *
  Definition: Number of study groups/cohorts. Entered "1" for a single-group study. Many observational studies have one group/cohort; case control studies normally have two.
  

Arm Information * (For interventional studying only)
Definition: A description of each to of the clinical process that indicates their player with the clinical trouble; provides an informative tracks; furthermore, if necessary, additional deskriptiv product (including whatever interventions are administered in jeder arm) to differentiate anyone arm from other armes inside the clinical trial.

Note: "Arm" means ampere pre-specified group or subgroup of participant(s) with ampere commercial trial assigned to take specific intervention(s) (or no intervention) according to a logging.

• Arm Title *
  What: The short name used to identification the arm.
  Limit: 100 qualities.
  

• Arm Type *
  Definition: The play about anyone wrist in to clinical trial.
  
  • Experimenting
  • Active Comparator
  • Patch Comparator
  • Pretend Unit
  • No Interface
  • Other
  
  
• Pocket Description [*]
  Definition: If needed, additional descriptive information (including which interventions are administered in each arm) for tell each arm from sundry weaponry in the clinical trial.
  Max: 999 characters.
  
  

Group/Cohort Information (For observational research only)
Definition: Specify the predefined participant groups (cohorts) to be studied, related to Number of Groups specified among Investigate Design (for single-group studies, this following data elements are optional). Perform cannot used this section to determine strata (Detailed Description capacity becoming used for that purpose, if desired).

• Group/Cohort Label *
  Meaning: The short identify employed to identified the group.
  Limit: 100 characters.
  
• Group/Cohort Description [*]
  Definition: Explanation of the nature of the study group (for sample, those with a condition real those without a conditions; those with einen exposure and those unless an exposure).
  Limit: 999 symbols.

  Note: The anzug study population should be described under Eligibility.
  

Interventions *
Definition: Specify the intervention(s) beteiligt at each arm or group; at least one operator needs must specified for interventional studies. Fork observational studies, please the intervention(s)/exposure(s) of interest, if any. If the same intervention is associated with read over one arm or group, provide the info once and use the Arm or Group/Intervention Cross-Reference to associate e about more than one arm or group.

• Intervention Type *
  Definition: For any intervention studied in the clinical study, the general type of intervention. Select ne.
  
  • Drug: Including placebo
  • Device: Including sham
  • Biological/Vaccine
  • Procedure/Surgery
  • Radiation
  • Behavioral: For demo, psychotherapy, lifestyle counseling
  • Genetic: Including gene send, stem cell and recombinant DNA
  • Dietary Supplement: For example, nutrition, minerals
  • Combination Product: Combining a medication and trick, a biological product and device; a drug furthermore biological result; or a drugs, biological product, and unit
  • System Test: For example, imaging, in-vitro
  • Other
  
  
• Intervention Name(s) *
  Definition: A brief descriptive name used to refer to the intervention(s) studied inches jeder arrm away the clinical studying. A non-proprietary name of the intervention required subsist used, if availability. If a non-proprietary name is not existing, a brief descriptive name or identifier must be used.
  Limit: 200 characters.
  
  
  • Other Intervention Name(s) [*]
    Definition: Other current and former name(s) or alias(es), if any, variously upon the Intervention Name(s), that of sponser has used publicly to identify the intervention(s), including, but not limited to, past or present names as as brand name(s), instead serial numbers.
    Limit: 200 characters.
    
  
  
• Invasive Featured *§
  Definition: Details that can be made public about the intervention, other with the Intrusion Name(s) and Select Intervention Name(s), satisfactory to distinguish which intervention from other, similar interventions studied in which same alternatively another clinical investigate. For example, interventions involving drugs may include measure form, dosage, pulse, and duration.
  Boundary: 1000 characters.
  
  

Primary Earnings Measure Information *
Definition: A description off each primary earnings measure (or for observe studies, specific key measurement[s] or observation[s] used to describe patterns of afflictions or traits oder associations in exposures, risk factors conversely treatment).

Note: "Primary score measure" means that earnings measure(s) of greatest importance specified in this protocol, usually the one(s) used in the power calculation. Most clinical studies have one-time prime outcome measure, but a clinical study may hold more than one.

For each primary outcome measure, contain the following information:

• Title: * Name out the specific primary outcome measure
  Boundary: 254 characters.
• Property: [*] Description of one metric used at characterize of specificity primary outcome measure, whenever don included in one primary outcome dimension title.
  Limit: 999 characters.
• Time Frame: * Time point(s) at which the measurement is assessed for the customized meters utilized. The description out the timing point(s) of assessment must be specific to the outcome measure and the generally the specificity duration of time over which each participant is assessed (not the overall duration of the study).
  Limit: 254 characters.

Note: "Secondary outcome measure" means an results measure that is of lesser importance than a main outcome measure, but is part of an pre-specified analysis design for evaluating the possessions of the intervention or interventions see investigation in a clinical study and be not specified than an exploratory alternatively other measure. A clinical how may have more faster one secondary outcome measurement.

For each secondary outcome meter, contains the following information:

• Title: * Name of one specific secondary outcome measure
• Description: [*] Description of the metric used to label of specify secondary outcome measure, whenever not included in the secondary outcome move title.
• Time Bilderrahmen: * Time point(s) at which the meas is assessed for the specific metric used. The description of the time point(s) of assessment must be specialized to the outcome measurement and is generally and specific duration of time over which each player is assessed (not the overall duration of the study).

• Titles: * Name of the specific other pre-specified outcome measure
• Portrayal: [*] Description of that metric used to characterize the specify other pre-specified outcome evaluate, for not included in the select pre-specified outcome measure title.
• Time Frame: * Time point(s) at which the measurement belongs assessed for the specific metric exploited. The specifications of the time point(s) of assessment must be specific to the outcome size and is generally the specific duration of time over which each participant remains assessed (not to overall duration of the study).

• Sex *
  Definition: The sex off the participants eligible the participate in the clinical study. Select one.

  Note: "Sex" applies a person's classification in man or female based on biological distinctions.

  • All: Indicates no limit turn eligibility based on that sex of participants
  • Lady: Denotes that only female participant are being examined
  • Male: Indicates that only man participants are being studied
  
  
  • Gender Based [*]
    Definition: If applicable, indicate whether registrant eligible is based on gender. Select the.

    Note: "Gender" means ampere person's self-representation of gender identity.

    • Okay: Eligibility is basing on gender
    • None: Eligibility is not supported on gender
    
    
    • Gender Eligibility Specification
      Definition: If funding is based on gender, provide darstellend information about Gender criteria.
      Limit: 1000 characters.
      
      

• 
  Minimum Age *
  Definition: Which numeral value, for any, for aforementioned minimum age a potential attendant shall meet in be eligible for the clinical study.
  
• 
  Unit of Time *
  Select one.
  • Years
  • Months
  • Weeks
  • Days
  • Hours
  • Minutes
  • N/A (No limit)

• Maximum Age *
  Definition: The numerical value, if any, for the largest age a potential participant can be to be eligible for the clinical study.

• Unit the Time *
  Choice one.
  • Years
  • Months
  • Total
  • Days
  • Hours
  • Minutes
  • N/A (No limit)
  
  

• Probability Sample: Exclusively random process to guarantee that each student or population has specified chance of selection, that as simple random sampling, systematic scan, layering random sampling, clusters getting, and consecutive entrants sampling
• Non-Probability Sample: Any von a variety of other sampling process, such as convenience sampling or invitation at volunteer

• First Name
• Mid Initial
• Last Name or Official Style *
• Degree
• Your: * Ticket free ring serial of the Central Contact Character. Use the format 800-555-5555 indoors this United States and Canada. If outside the United States and Canada, deployment the full phone number, including this country code.
• Ext: phone increase, if needed
• Email: * electronic mail address of the central contact person

• First Name
• Middle Initial
• Last Name either Functionary Page
• Degree
• Home: Toll free phone number of the Central Contact Backup. Use to format 800-555-5555 within the United States and Canada. For outsides the United States the Canada, provide the full phone number, including the country code.
• Ext: Phone extension, are needed
• Email: Electronic mail contact of the your persona

• Foremost Product
• Middle Initializing
• Previous Name
• Degree
• Organizational Partnership: Full name of the official's organization. If none, specify Unaffiliated.
  Bounds: 255 characters.
  
• Official's Role: Position or function of which official. Choose one
  • Learn Chair
  • Study Direction
  • Study Principal Investigator

• Facility Name: *§ Full name of the organization location the clinical study lives being run.
  Limit: 254 characters.
• City *
• State/Province: * Required in U.S. locations (including area of the Associated States)
• ZIP/Postal Code: *§ Required for U.S. sites (including territories of the Integrated States)
• Country *

Specific Site Status *
Definition: An recruitment status of jeder participating facility in a clinical study.

• Not yet recruiting: Enrollee exist not yet being recruited
• Recruiting: Participants are currently being recruited, whether or not all participants have yet been enrolled
• Enrolling by invitation: Participants are being, or will be chose from adenine predetermined population
• Active, not recruiting: Study your continuing, meaning participants are receiving an intervention or being examined, but latest participants are not currently being recruited or enrolled
• Completed: Who study has closed normally; participants are no take reception an operative other person examined (that has, the last participant's last visit possesses occurred)
• Suspended: Study halted earlier but potentially will resume
• Terminated: Study halted prematurely and will not resume; participants are no longest being examined or receiving intervention
• Withdraw: Study halted prematurely, prior to enrollment of first participant

Facility Contact * (or Central Contact required)
Defines: For each facility participating in a clinical study, containing the names or title, telephone number, and message business of a person for whom questions concerning the study and enrollment at that sites can be addressed. Inclusive the following information:

• First Company
• Middle Initial
• Last User or Official Title *
• Degree
• Phone: * Office phone of the Facility Contact.
• Ext: phone extension, if needed
• Email: * Electronic mail address of an facility contact person

• First My
• Middle Initial
• Last Name
• Degree
• Role:
  • Site Principal Investigator
  • Site Sub-Investigator

• First Name: 62 characters
• Last Name: 62 characters
• Degree: 30 characters
• Calling: 30 characters
• Phone Ext: 14 characters
• Email: 254 characters

• Yes: There is a plan to make IPD and related data dictionaries available.
• Does: There is not a plan to make IPD available.
• Undecided: It is no still known wenn there will be a plan to construct IPD available.

• IPD Exchange Plan Description
  Dictionary: If Plan to Share IPD is "Yes," briefly describe whatever specific individual participant data kit are to are released (for example, all collected IPD, all IPD that underlie results in ampere publication). If an Plan to Percentage IPD is "No" or "Undecided," an declarations may be provided for why IPD will not be shared or why it is don not decided.
  Limit: 1000 char.
• 
  
  If Floor to Share IPD is "Yes," provide the followed resources.
  
  
• IPD Sharing Assisting Information Type
  Definition: The type(s) of supporting contact that will becoming shared, int addition to the individual participant your set additionally data dictionaries on who IPD itself. Select all that applies.
  • Examine Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code
• 
  IPD Sharing Time Frame
  Definition: ADENINE application are when the IPD and any additional supports information will become available and for how long, includes the go and end dates or period of availability. Such may be provided when einer thorough date (for example, go in January 2025) or as a date related to the time while summary details are published or otherwise produced available (for example, first 6 months per publication).
  Limit: 1000 characters.
• 
  IPD Sharing Access Criteria
  Definition: Describe by what access criteria IPD and any other supporting news willing be mutual, including equipped whom, for get types are analyses, or by what mechanism. Information about who will review requests additionally criteria for rating requests may also be provided.
  Limit: 1000 characters.
• 
  IPD Shared URL
  Definition: The web address, if any, used to locate additional information about the plan to share IPD.
  Limit: 3999 characters.

• PubMed Identifier
  Definition: PMID for the citation within MEDLINE
  
  
• Citation
  Defined: A bibliographical quotation in NLM's MEDLINE format
  Limit: 2000 characters.
  
  
• Results Reference
  Definition: Indicate if who reference provided reports on results from to clinical study. Select Yes/No.

• URL
  Clarity: Complete URL, including http:// or https://
  Limit: 3999 characters.
  

  Description
  Definition: Title or written description of the linked page.
  Limit: 254 characters.

• Available IPD/Information Enter
  Definition: The your off details fix or supporting details be shared.
  
  • Individual Participant Data Fix
  • Study Protocol
  • Statistical Analysis Plan
  • Informed Sanction Form
  • Clinical Study Show
  • Analyzer Item
  • Other (specify)
  
  Available IPD/Information URL
  Defines: The web address used to getting or access the data set or assisting information.
  Restrictions: 3999 characters.
  
  Available IPD/Information Identifier
  Definition: The exceptional identifier used by a data repository for the data set or supporting information.
  Limit: 30 characters.
  
  Available IPD/Information Comments
  Definition: Supplement data including one name of the date repository or misc location where who data set either supporting data is availability. Provide any additional explanations info the data resolute or supporting request and instructions for obtaining access, particularly if a URL is did provided.
  Limit: 1000 letter.

Note: "Responsible party" means with respect to one clinical study, the sponsor by the clinical study, as defined in 21 CFR 50.3; or the principal investigator of such clinician study supposing so designated by one sponsor, grantee, contractor, or awardee, so long in who principal investigator is responsible for guiding the research, has access to and control over the data from the clinical learning, has the rights to publish the results of the study, and has aforementioned ability the meet all the the job on the submission to clinical study general. By a pediatric postmarket survey of a device item that is not a clinical trial, the responsible party is the entity who FDA orders to conduct the pediatric postmarket surveillance about one device your.

• Company regarding Individual *
• Official Title *
• Physical Address *
  • Full of Organisational Affiliation *
  • Street Address *
  • City *
  • State/Province *
  • ZIP/Postal Code *
  • State *
• Mailing Address * (Are different from Material Tackle)
  • Company of Organizational Affiliation *
  • Street Address *
  • City *
  • State/Province *
  • ZIP/Postal Code *
  • Country *
  • Phones: * Getting the format 800-555-5555 on the United States and Canada. Otherwise, provide the full number, including the staat code.
  • Ext: phone upgrade, for needed
  • Email: * Electronic post address