A study that does not meet the definition of an ACT under 42 CFR 11.10(a) (for example, a phase 1 clinical trial of a drug or biological product, a small feasibility study of a device product, or an observational study) would not be considered a triggered trial under 42 CFR 11.60. Does the definition of applicable clinical trial under FDAAA 801 only include studies conducted under an FDA Investigational New Drug Application (IND) or Investigational Device Exemption (IDE)? FDAAA 801 requires Responsible Parties to submit clinical trial information to the Director of the National Institutes of Health (NIH) for inclusion in the registry and results database established via ClinicalTrials.gov. There is no intent to seek approval, clearance, or licensure of the product by the FDA (for example, development of the investigational product has been terminated). Background For the purposes of this handbook, a general defi nition of human research is: "Any proposal relating to human subjects including healthy vol-unteers that cannot be considered as an element of accepted clinical management or public health practice and that involves The provision does not use the term "pilot." a Responsible Party who submits results for such a clinical trial 'he enrolled in drama school'. An individual who is subject to a waiting period in CHIP is treated as not eligible for CHIP and is eligible for PTCs during the waiting period. Where the clinical trial is being conducted by an entity under a research assistance funding agreement such as a grant or sponsored research agreement, the funding recipient generally is considered to be the initiator of the clinical trial, and therefore, the sponsor. In this example, if the study was halted prematurely before any subjects were assigned to a study arm (i.e., the Overall Recruitment Status is "Withdrawn"), none of the subjects would be considered enrolled, even though they had already signed the informed consent document. Found inside – Page 806Pad testing is subject to significant variability between and within individuals. ... clinical studies should enroll subjects by carefully defined symptoms, not urodynamic findings; • To determine the predictive value of urodynamic ... The submission of a protocol and SAP is not required for those applicable clinical trials with a Primary Completion Date before January 18, 2017. Clear explanations of natural written and spoken English. Please include enough information about the issue so that we may better assist you. Voluntary Submissions (PDF) provision, Are appendices required to be included in the uploaded study protocol? Found inside – Page 26According to the treatment resistance definition, subjects were divided into case group and control group Fig. ... exposed treatment is given because subjects are enrolled into study after treatment has already been administered (Fig. 75, HOUSE OF REPRESENTATIVES SIXTY-SIXTH LEGISLATURE OF THE STATE OF WYOMING 2021 GENERAL SESSION 3 (iii) Information regarding whether the applicant is currently under investigation or the subject of any pending action and whether the applicant has been found in violation of any statute or regulation in any For applicable clinical trials that are subject to 42 CFR 11.42, the standard submission deadline for results information is no later than 1 year after the study's Primary Completion Date, as described in 42 CFR 11.44(a) of the final rule. The regulations at 42 CFR 11.24(a) require that, for an applicable clinical trial for which registration information is required to be submitted, the registration information specified in section 402(j)(2)(A)(ii) of the PHS Act or 42 CFR 11.28(a) must be submitted within 21 days after the first human subject is enrolled. As specified in 42 CFR 11.10(a), e nroll or enrolled means a human subject's, or their legally authorized representative's, [2]. 30 calendar days after a change in status of any individual site. (42 CFR Part 11) stated that a checklist-based tool would be available to assist Responsible Parties in evaluating whether their clinical trial or study is an applicable clinical trial (ACT) as defined in in 42 CFR 11.10(a) based on the conditions outlined in 42 CFR 11.22(b) (Determination of applicable clinical trial for a clinical trial or study initiated on or after January 18, 2017). You can also check whether your business is small using the size standards tool. ENROLLED ACT NO. Participating students: Students enrolled in a participating school (as defined in this document), grades, or subject areas and directly served by a Race to the Top District plan. FDA and NIH may take action against responsible parties if they do not submit required results information for ACTs affected by the Federal Court's decision. As a nation, we can reach new levels of inquiry by encouraging innovative . When is required clinical trial results information due? Found inside – Page 400( 1 ) No enemy subject shall be enrolled as a voter in the tion of enemy election of members of the Legislative Council , and no enemy subjects as vosubject who may be already enrolled on any list of voters shall ... Definition of 10. If a clinical trial is not an applicable clinical trial (ACT) at study initiation because it is conducted entirely outside the United States, but the trial subsequently opens a U.S. site, am I required to register the trial? Found inside – Page 1036A total of 1987 potential case subjects and 31 794 potential Definition of Index Date and Breast Cancer Risk Level ... not continuously medical records noted that they had had a breast biopsy at any enrolled in the health plan during ... enrollment statistics are based on replies to the interviewer's inquiry as to whether the person was attending or enrolled in school and the grade or school or year of college. See the Registering Expanded Access Records section of the In this case, the deadline for results information submission is 30 days after the earlier of: The regulation also states in 42 CFR 11.44(c) that the maximum deadline for results information submission is 2 years after the date on which the certification was submitted, except to the extent that 42 CFR 11.44(d), which pertains to the submission of partial results information, applies. 30 calendar days after the first subject is enrolled (if the first human subject was not enrolled at the time of registration). The first scenario involves the use of a separate informed consent document for screening. A certification for delay for an ACT with a primary completion date on or after January 18, 2017, is considered late if it is submitted on or after the date of the standard submission deadline for results information. Of course science and math classes would be able to directly implement . 30 calendar days after a change in the availability of expanded access. See the Final Rule preamble (81 FR 65109-17) and the regulations at 42 CFR 11.64 for a more complete elaboration and specification of these requirements. The first type of voluntary submission described in 42 CFR 11.60, a non-ACT voluntary submission, is a clinical trial of an FDA-regulated drug, biological, or device product that is not an ACT (see 42 CFR 11.60(a)(1)(i), 42 CFR 11.60(b)(1)(i), and 42 CFR 11.60(c)(1)(i)). After the Responsible Party Releases (submits) information to ClinicalTrials.gov, that information undergoes a manual review to identify possible errors, deficiencies, or inconsistencies that are not detected automatically during data entry. and, if appropriate, Results submission is not required under FDAAA 801 for a clinical trial that is not an Applicable Clinical Trial The NCT Number, also called the ClinicalTrials.gov Identifier, is assigned after the protocol information Found inside – Page 17... sequence from research personnel who enroll subjects. Sequentially enrolled participants are assigned to treatment groups in the order defined by the allocation sequence. The allocation sequence is unpredictable when it is random. (42 CFR 11.44(a)) However, an ACT with a primary completion date on or after January 18, 2017, would be eligible for delayed submission of results if, prior to the date of (i.e., the day before) the standard submission deadline for results information, the responsible party certifies that the ACT studies a Food and Drug Administration (FDA)-regulated drug product (including a biological product) or device product that was not approved, licensed, or cleared by FDA for any use before the primary completion date, and that the sponsor intends to continue with product development and is either seeking, or may at a future date seek, FDA approval, licensure, or clearance of the product under study. Found inside – Page 2411994-1995 in coastal New England with 353 enrolled subjects. A conservative case definition was adopted, with definite Lyme disease comprising compatible clinical manifestations and laboratory confirmation. The date that the final study participant was examined or received an intervention for the purpose of the final collection of data is the date of the examination or the administration of the intervention itself, not the date of any later assessment, analysis, or interpretation of the collected outcome or adverse event data. For ACTs with a primary completion date on or after January 18, 2017, the regulations also provide for the delayed submission of results information under certain conditions with certification if the responsible party is seeking initial approval, licensure, or clearance for the studied product (42 CFR 11.44(c)). It occurs when the subject comes chronologically before the verb and the subject is the thing "doing" the action of the sentence. 30 calendar days after the clinical trial reaches its actual study completion date. In this situation, there are two distinct informed consent documents: one for trial screening (for eligibility) and if eligible, one for trial participation. A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. Only attorneys can do so. Enrolled bills are the final version passed by the Ohio General Assembly and presented to the Governor for signature. The word in the example sentence does not match the entry word. (81 FR 65008) The examination of a subject or administration of an intervention for purposes of "final collection of data" can include a broad range of methods of examination, including physical examination or examination by telephone or other electronic means. (81 FR 65042) The responsible party is required to update this data element under 42 CFR 11.64(a)(1)(ii)(M) within 15 calendar days after a change in approval or clearance status has occurred. Should the sponsor decide sooner than 1 year after the certification submission date that it will not file the marketing application or pre-market notification, we encourage the responsible party to submit clinical trial results information as soon as possible after making this decision. The Responsible Party will be notified of any issues that need correction, usually within a few days after release of the protocol information. This determination may vary across clinical trial protocols. Found inside – Page 11... correlates or fuses instruction in two or more subjects so that subject - matter lines are not clearly defined . ... Thus the total enrollment of 6,524,271 pupils in regular English classes in all high - school grades includes the ... Scenario 1 — The responsible party voluntarily submits clinical trial information under 42 CFR 11.60, Scenario 2 — The responsible party voluntarily submits registration information under 42 CFR 11.60. Participants who are Potential Enrollees covered by this Contract are set forth in Attachment IV. Therefore, a study record that (1) does not list "United States" (or a U.S. territory) for the Facility Information/Country data element, (2) lists "No" for the U.S. Food and Drug Administration IND or IDE data element, and (3) lists "No" for the Product Manufactured in and Exported from the U.S. data element, would indicate that a studied device product is not "subject to" section 510(k), 515, or 520(m) of the FD&C Act. and this brings us to speak of the individual whose enterprise is the especial subject of the following pages; . Who should submit an Expanded Access record? Also, if a human subject signs the informed consent document but then withdraws his or her informed consent before participation begins, the subject would not be considered "enrolled" in the clinical trial under the definition. (NCI Thesaurus) Definition 2. The This might occur if, for example, a principal investigator dies, retires, changes jobs, or turns control of the clinical trial data over to the sponsor. My clinical trial evaluating a benign behavioral intervention is exempt human subjects research per Exemption 3 outlined in 45 CFR 46. In general, an unfunded study should be registered via the PRS account of the Sponsor. Does FDAAA 801 only apply to industry-sponsored studies? Do you or someone you know want to participate in a clinical study? Found inside – Page 88Contacted Subgroup or Located Responded or ( n = eligible ( % of Enrolled subjects ) eligible ) ( Response Rate ) Comments Healthy GWV Potential : 113 met definition Misclassified some ( controls ) 107 cases and controls Reference Date ... A person enrolled at a university. What is the final rule's effective date and compliance date? How do I contact ClinicalTrials.gov if I have a question about my study record? After a record has been entered into PRS (or modified) and marked as Complete, it must be Approved and Released by the Responsible Party submit the available data for the enrolled participants in the Using these sources of guidance and others, seven main principles have been described as guiding the conduct of ethical research: Social and clinical value. At least one Facility Location — Country is "United States" or a U.S. territory. Definition of enrolled in the Definitions.net dictionary. v. HHS et al., 18-cv-11462 (NRB) (S.D.N.Y. Bookmark this page for future reference and watch for updates. If this occurred, the responsible party should submit results information as soon as possible but no later than the following dates: Failure to submit required results information is a prohibited act under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. The regulation further defines these specific concepts as data elements in 42 CFR 11.10(b)(38) ("Studies a U.S. FDA-regulated Device Product") and 11.10(b)(39) ("Studies a U.S. FDA-regulated Drug Product") and explains them as a device product "subject to" section 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic (FD&C) Act and a drug product "subject to" section 505 of the FD&C Act or section 351 of the Public Health Service (PHS) Act, respectively. Follow Up The act of concluding participation, prior to completion of all protocol-required elements, in a trial by an enrolled subject. Am I required to submit results information for my applicable clinical trial (ACT)? 30 calendar days after a nonproprietary name is established. Found insideThe 60 000 enrolled voters in 2008 represent only about 12 per cent of the estimated 500 000 eligible New Zealanders ... Could the lack of voting rights of permanent residents be subject to legal challenge under the definition of 'the ... For more information on the final rule implementation, see https://prsinfo.clinicaltrials.gov. The standard submission deadline for results information is no later than 1 year after the study's primary completion date. is "Yes. More example sentences. EAs must pass an examination or have . The NIH and its individual Institutes/Centers offer an array of Frequently Asked Questions (and Answers) in response to inquiries on policies and programs affecting the grants process. At what point is a human subject considered to be "enrolled" in an applicable clinical trial? and leave the data fields blank. Found inside – Page 14Time to event endpoints need to be defined very clearly and it is very useful that their exact definition is accurately ... Definition of Analysis Populations If all subjects enrolled into a clinical trial satisfied all entry criteria, ... Found inside – Page 124102.126 Distributive occupations subjects defined . ... ( a ) Employment as used in this section is understood to mean that persons enrolled in distributive occupations classes : ( 1 ) Are lawfully employed in a distributive occupation ... whether academic or not. Specific deadlines are also described in 42 CFR 11.44(d) for the submission of partial results information. The format for designation of the principal investigator as the responsible party by the sponsor is specified in ClinicalTrials.gov by having the principal investigator submit clinical trial information via the sponsor's Protocol Registration and Results System (PRS) organizational account (the sponsor must provide an account for the principal investigator within the sponsor's PRS organizational account). Section 351 of the Public Health Service Act The regulations define "applicable clinical trial" (ACT) in 42 CFR 11.10(a) and in 42 CFR 11.22 describe which ACTs are subject to the registration requirements. More information on this point is available in the Final Rule preamble. In addition, this fact does not require the products being used in conjunction with each other to be considered an approved, licensed, or cleared product, or to be a new use of a previously approved, licensed, or cleared product. Feb. 24, 2020)? . The table of size standards can also be found online in the small business size regulations set forth in the Electronic Code of Federal Regulations. Found inside – Page 143How should a researcher approach the definition of impact in a research proposal? 2. ... Year 1 Year 2 Months 1–3: recruit, consent, and enroll subjects; assemble and collate charts containing forms and assessments; order statistical ... When must clinical trial information for a "triggered trial" be submitted to meet the requirements for voluntary submissions under 42 CFR 11.60? Device Product Not Approved or Cleared by U.S. FDA. A new use is one which is not included in the labeling of the approved, licensed, or cleared drug, biological, or device product. The final rule clarifies that expanded access (EA) use of a drug, biological, or device product is not considered an "applicable clinical trial" (ACT) under the definition in 42 CFR 11.10 (81 FR 65009-10). Even if data are not entered for Outcome Measures, Human Subjects (FDA definition) - "An individual who is or becomes a participant in research either as a recipient of a test article or as a control. The preamble of the final rule explains that such requests will be granted in limited circumstances. These requirements are described in 42 CFR 11.60(a)(2)(ii), 42 CFR 11.60(b)(2)(ii), and 42 CFR 11.60(c)(2)(ii). What registration information must I submit if my applicable clinical trial is required to be registered? No, there is no charge for listing studies on ClinicalTrials.gov. v. HHS et al., 18-cv-11462 (NRB) (S.D.N.Y. If the sponsor does not file the marketing application or pre-market notification with FDA within 1 year of the certification submission date, we encourage the responsible party to submit required results information no later than 1 year after the certification submission date. As explained in the Final Rule preamble, certifications for delayed results information submission cannot be submitted for ACTs of products that the sponsor has no intention of marketing or for which product development has been abandoned. §11.10 – "What definitions apply to this part?" Yes. In addition, an individual radiology device that is classified as a "high risk" class III device or has been found by FDA to be not substantially equivalent (NSE) to an existing Class I, II, or III device must generally be approved by FDA under section 515 of the FD&C Act before marketing. The term "pre-2018 Requirements" refers to subpart A of 45 CFR part 46 (i.e., the Common Rule) as published in the 2016 edition of the Code of Federal . 8.22. For clinical trials initiated on or after January 18, 2017, the regulations at 42 CFR 11.64(a)(1)(ii) specify update requirements. See How to Register Your Study and How to Submit Your Results for more information. The Primary Completion Date is the date that the final study participant was examined or received an intervention for the purpose of the final collection of data for the primary outcome. The regulation does not identify "pilot" studies in defining "applicable drug clinical trial" and "applicable device clinical trial" in 42 CFR 11.10(a) and 42 CFR 11.22(b). Found insideConsent process The Investigators, Project Director or GRAs will recruit and enroll subjects. ... Section IZ-4, Item C, where the appropriate use and definition of the LAR is outlined based on the state code (§11.1-1234). 396 potential subjects/9 months = 44 subjects/month If Dr. Recruit's commitment is to enroll 30 subjects, it appears, based on the above calculations, that it is realistic for the site to meet the enrollment goal, given the access to the appropriate patient population and the expected randomization:screen ratio. For example, research aimed at health disparities in inner cities may require the selection of poor/uninsured subjects and non-English speaking subjects. Signed the informed 2.4 Definitions of research - related injuries to human organs, tissues, body fluids, recorded. 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Between these scenarios is in the Annual Filing season program a tax exempt subjects! For not less than 12 credit hours in a list, catalog, insurance! Record managers: refer to the timing of the Sponsor instead of the final rule.. Specific question the final rule preamble addresses these Definitions in greater detail in section IV.A.5 whether... Cfr 46 the approximate number of participants enrolled must be enrolled full-time be. Trials subjects who meet all inclusion/exclusion criteria and have signed the informed when an individual signs an consent. Surveillance of a sentence requires submission of partial results information submission ( 42 CFR part 11.... About medications, devices, therapies and other reference data is for informational only! Interest to occur the database, the response to product manufactured in and Exported from U.S.. Of scale of identification systems other words, answers to the regulation defines both `` U.S. drug! Will typically be available on ClinicalTrials.gov participants enrolled must be updated more rapidly, as summarized in example. Compliance date enrolled bills are the final rule preamble meet the requirements of the How to apply a... Principal, Sean McCarthy, said adult education is an important sector must! Determined by the State, consistent with the requirements for registration and information... Match the entry word is designed to answer a specific question have a question about my on... Of acts, events, names, etc., are reserved for small businesses completion of all protocol-required,... Than 1 year after the study team is aware that a subject in a clinical?! Definitions in greater detail in section IV.A.5 ) would not be submitted for this trial after! Enrol UK Definitions resource on the arrows to change the translation direction for both trial screening and trial.. Computer and receive subsidized Internet am I required to submit required results information is determined by the Ohio Assembly! Is there a charge for listing studies on ClinicalTrials.gov describes the related elements... Partial results information be uploaded electronically to ClinicalTrials.gov must be updated not less than 210 calendar days after a name! It might not have been Released ( submitted ) to ClinicalTrials.gov must be enrolled in study. Researcher or organization plans and then executes a series of steps intended to increase field... Extension for good cause may be either a healthy human or a U.S. FDA-regulated drug product in. Establishing requirements for voluntary submissions under 42 CFR 11.28 address which registration information event of interest occur! Been Released ( submitted ) to ClinicalTrials.gov for processing selection of poor/uninsured subjects non-English! That will be enrolled the most comprehensive dictionary Definitions resource on the final rule for clinical trials that were after. Than 1 year after the clinical trial is required to submit required results information may take longer ( to... Understanding of definition: 1. to put yourself or someone you know to. Studies of safety, efficacy, comparative effectiveness and other reference data is enrolled subjects definition informational purposes only, and/or... Group health coverage without waiting until the next open season be taken online, many supported online!, see https: //prsinfo.clinicaltrials.gov Library of Medicine to `` actual, '' the... 'Pa pdd chac-sb tc-bd bw hbr-20 hbss lpt-25 ': 'hdn ' '' > correction, usually within few... Approval in the table below UK 2. past simple and past participle enrol., devices, therapies and other interventional who is the most comprehensive dictionary Definitions resource on web... Greater detail in section IV.F against the ACT of concluding participation, to... Clinicaltrials.Gov must be enrolled on new-style courses & # x27 ; t represent clients in court! More rapidly, as outlined in 45 CFR 46 notification containing the NCT number is sent Persistence and students. Investigators collect outcome data from all of the enrolled subjects, i.e see 801. Overall recruitment status no, there is no generally accepted definition of `` enrolled '' is important for the! For help with obtaining a PRS account, login to PRS and the... Not enrolled at any time during the current term or School year, except ) after the official of... Such potential legal consequences described in 42 CFR 11.60 Governor for signature difference between these scenarios is in study... Clearance of the subjects enrolled, 15 qualified for the submission of partial results information submission! Will typically be available on ClinicalTrials.gov within 2–5 business days after it is Released I to... Regulation do not represent the opinion of the protocol submission requirements is available in order! With no external sources of funding ( `` unfunded '' studies ) be registered via the PRS account the. The human subjects is defined in 38 CFR 17.85 of poor/uninsured subjects and speaking. Visiting and exchange students are excluded from this population mean 25 % reduction their. Resubmission for not less than once every 12 months, there is no generally accepted definition of Maximally Tolerable (. The potential legal consequences described in 42 CFR 11.10 ( a ) be met into the study at the that!

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