.rT$c` "qacZ=2{N.Y.Pf/gV4*TR5n_trO4r4mn~Fh|(` b You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. These concerns have been raised particularly in the areas of part 11 requirements for validation, audit trails, record retention, record copying, and legacy systems. You should also consider the impact those systems might have on the accuracy, reliability, integrity, availability, and authenticity of required records and signatures. Center for Food Safety and Applied Nutrition, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research, An official website of the United States government, : endstream endobj startxref FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Any of the following will satisfy the initial and/or continuing education GCP training requirement: The .gov means its official.Federal government websites often end in .gov or .mil. 0000002946 00000 n Device Advice is CDRH's premier text-based resource that explains many aspects of medical device laws, regulations, guidances, and policies, encompassing the entire product life cycle. 0000004083 00000 n Individuals engaged in the conduct of a clinical trial (per the NIH definition) must complete a Good Clinical Practice (GCP) training. Manufacturers Assistance Phone Number: 800-638-2041 or 301-796-7100, Center for Food Safety and Applied Nutrition (CFSAN). Producing copies of records held in common portable formats when records are maintained in these formats, ISO/IEC 17799:2000 (BS 7799:2000) Information technology - Code of practice for information security management (ISO/IEC, 2000), ISO 14971:2002 Medical Devices- Application of risk management to medical devices (ISO, 2001), Current Good Manufacturing Practice (CGMP). Some have understood the scope of part 11 to be very broad. Part 11 also applies to electronic records submitted to the Agency under the Federal Food, Drug, and Cosmetic Act (the Act) and the Public Health Service Act (the PHS Act), even if such records are not specifically identified in Agency regulations ( 11.1). Persons must still comply with all applicable predicate rule requirements related to documentation of, for example, date (e.g., 58.130(e)), time, or sequencing of events, as well as any requirements for ensuring that changes to records do not obscure previous entries. -Zi$WS*nVEB},BWtpq _Y +G6;Hm+-sAeA|3PM pPV&/e=E'$ a%Q;75i+-[f 4 See Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach; A Science and Risk-Based Approach to Product Quality Regulation Incorporating an Integrated Quality Systems Approach . We recommend that you determine, based on the predicate rules, whether specific records are part 11 records. CCRPS provides accredited, industry-recognized on-demand advanced ICH GCP course covering ich gcp guidelines, ich gcp e6 r2, ich gcp sae reporting, and other updated ich gcp guidelines through ich gcp training transcelerate. The site is secure. Interested parties have a number of opportunities to provide input into guidance development. The Agency intends to exercise enforcement discretion with regard to the part 11 requirements for the protection of records to enable their accurate and ready retrieval throughout the records retention period ( 11.10 (c) and any corresponding requirement in 11.30). za][LQ %@Hsq]t]% 60073 QA{,'F'K +*TAt &8/ ["TUD09k&ofL+Ds cL0Ha` @19*tL3o8uUh3J\O,g7"}.-= xm{Nei;];CKy4Sb`\ We understand that there is some confusion about the scope of part 11. Silver Spring, MD 20993 The system met all applicable predicate rule requirements before the effective date. WO51, Room 2201 The Agency intends to exercise enforcement discretion regarding specific part 11 requirements related to computer-generated, time-stamped audit trails ( 11.10 (e), (k)(2) and any corresponding requirement in 11.30). Office of Training and Communications Division of Drug Information Center for Drug Evaluation and Research (CDER) WO51, Room 2201 10903 New Hampshire Ave FDA oversees clinical trials to ensure they are designed, conducted, analyzed and reported according to federal law and good clinical practice (GCP) regulations. You have documented evidence and justification that the system is fit for its intended use (including having an acceptable level of record security and integrity, if applicable). Good Clinical Practice Training. In the Federal Register of February 4, 2003 (68 FR 5645), we announced the withdrawal of the draft guidance for industry, 21 CFR Part 11; Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records. A locked padlock) or https:// means you've safely connected to the .gov website. 5 Although we withdrew the draft guidance on time stamps, our current thinking has not changed in that when using time stamps for systems that span different time zones, we do not expect you to record the signer's local time. 0000005378 00000 n xb```b````_Y8 As mentioned previously, part 11 remains in effect during this re-examination period. 0000000016 00000 n endstream endobj 946 0 obj <>/Size 933/Type/XRef>>stream As an outgrowth of its current good manufacturing practice (CGMP) initiative for human and animal drugs and biologics,4 FDA is re-examining part 11 as it applies to all FDA regulated products. Additionally, FDA accepts Pre-Submissions, in which you can submit information to FDA and receive advice on topics such as a non-clinical testing plan and/or a draft clinical protocol. 5.1.1 The sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s).. 5.1.2 The sponsor is For example, we intend to enforce provisions related to the following controls and requirements: We expect continued compliance with these provisions, and we will continue to enforce them. 50.20 General requirements for informed consent. 0 In each case, we recommend that the copying process used produces copies that preserve the content and meaning of the record. For GCP, on-demand pricing of memory-optimized instances was the highest, but the 1-year commitment price is the lowest among all three cloud providers. Rockville, MD 20852. We recommend that you supply copies of electronic records by: Using established automated conversion or export methods, where available, to make copies in a more common format (examples of such formats include, but are not limited to, PDF, XML, or SGML). FDA has (1) spoken about part 11 at many conferences and met numerous times with an industry coalition and other interested parties in an effort to hear more about potential part 11 issues; (2) published a compliance policy guide, CPG 7153.17: Enforcement Policy: 21 CFR Part 11; Electronic Records; Electronic Signatures; and (3) published numerous draft guidance documents including the following: Throughout all of these communications, concerns have been raised that some interpretations of the part 11 requirements would (1) unnecessarily restrict the use of electronic technology in a manner that is inconsistent with FDA's stated intent in issuing the rule, (2) significantly increase the costs of compliance to an extent that was not contemplated at the time the rule was drafted, and (3) discourage innovation and technological advances without providing a significant public health benefit. This web page contains information about such events, both past and upcoming. FDAs bioresearch monitoring (BIMO) program is a comprehensive program of on-site inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA-regulated research. FDA Clinical Trial Requirements, Regulations, Compliance and GCP Virtual Conference This three day virtual conference, jointly Sponsored with the FDA, will share information regarding clinical research regulations and GCP guidelines and discuss methods to aid the research professional in their practice. Science and Research Special Topics, Recalls, Market Withdrawals and Safety Alerts, Clinical Trials and Human Subject Protection, Good Clinical Practice (GCP) Inspection Collaboration with International Regulators for Drug Development, Regulations: Good Clinical Practice and Clinical Trials, Clinical Investigations Compliance & Enforcement, FDA's Role: ClinicalTrials.gov Information, Good Clinical Practice Educational Materials, Reporting Complaints Related to FDA-Regulated Clinical Trials, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, FDA Takes Action For Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.Gov, FDA Publishes Guidance on Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank (August 2020), FDA Publishes Guidance on Institutional Review Board Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During COVID-19 Public Health Emergency, FDA issues Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Pandemic, FDAs bioresearch monitoring (BIMO) program, How to report complaints or problems about clinical trials to FDA, Reporting complaints related to FDA-regulated clinical trials. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. IyD Even if there are no predicate rule requirements to document, for example, date, time, or sequence of events in a particular instance, it may nonetheless be important to have audit trails or other physical, logical, or procedural security measures in place to ensure the trustworthiness and reliability of the records.6 We recommend that you base your decision on whether to apply audit trails, or other appropriate measures, on the need to comply with predicate rule requirements, a justified and documented risk assessment, and a determination of the potential effect on product quality and safety and record integrity. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. NIH Definition of a Clinical Trial. GCP is also much cheaper than AWS and Azure for computing optimized cloud-based instances, although its more expensive when it comes to the instance types of accelerated computing. Guidance documents describe FDAs interpretation of our policy on a regulatory issue (21 CFR 10.115(b)). We suggest that your decision on how to maintain records be based on predicate rule requirements and that you base your decision on a justified and documented risk assessment and a determination of the value of the records over time. If you have the ability to search, sort, or trend part 11 records, copies given to the Agency should provide the same capability if it is reasonable and technically feasible. 50.20 General requirements for informed consent. qMqYGjzx>dKf9^J]i{U(f|(0m We do not intend to re-issue these draft guidance documents or the CPG. You should allow inspection, review, and copying of records in a human readable form at your site using your hardware and following your established procedures and techniques for accessing records. While the re-examination of part 11 is under way, we intend to exercise enforcement discretion with respect to certain part 11 requirements. The .gov means its official.Federal government websites often end in .gov or .mil. Records that are required to be maintained under predicate rules, that are maintained in electronic format in addition to paper format, and that are relied on to perform regulated activities. The training must be refreshed every three years. FDA considers direct advertising for study subjects to be the start of the informed consent and subject selection process. ^23co;h E%|]V)Z^}z\e A}LM,`w8@ca`KK O( 2P&Ef2,FA .' 8 Examples of hybrid situations include combinations of paper records (or other nonelectronic media) and electronic records, paper records and electronic signatures, or handwritten signatures executed to electronic records. Accordingly, we recommend that, for each record required to be maintained under predicate rules, you determine in advance whether you plan to rely on the electronic record or paper record to perform regulated activities. 0000003274 00000 n Good Clinical Practice Training. k In March of 1997, FDA issued final part 11 regulations that provide criteria for acceptance by FDA, under certain circumstances, of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper. Share sensitive information only on official, secure websites. 0000004611 00000 n education, training, and experience (and state licensure where relevant) to perform the delegated task. Regulations regarding commercially distributed analyte specific reagents (ASRs) (21 CFR 809.10(e), 809.30, and 864.4020), and role/responsibilities of manuf. X$Drn1 jb }@"@}D>U0 That is, the Agency may take your business practices into account in determining whether part 11 applies. 933 0 obj <> endobj The agency works to ensure its GCP policies continue to facilitate new approaches to generating quality clinical evidence. On the other hand, records (and any associated signatures) that are not required to be retained under predicate rules, but that are nonetheless maintained in electronic format, are not part 11 records. For those records that remain subject to part 11, we intend to exercise enforcement discretion with regard to part 11 requirements for validation, audit trails, record retention, and record copying in the manner described in this guidance and with regard to all part 11 requirements for systems that were operational before the effective date of part 11 (also known as legacy systems). To avoid unnecessary resource expenditures to comply with part 11 requirements, we are issuing this guidance to describe how we intend to exercise enforcement discretion with regard to certain part 11 requirements during the re-examination of part 11. 0000001432 00000 n In addition, we intend to exercise enforcement discretion and do not intend to take (or recommend) action to enforce any part 11 requirements with regard to systems that were operational before August 20, 1997, the effective date of part 11 (commonly known as legacy systems) under the circumstances described in section III.C.3 of this guidance. Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgement. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. Part 11 will be interpreted narrowly; we are now clarifying that fewer records will be considered subject to part 11. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. 3955 0 obj <> endobj As long as predicate rule requirements are fully satisfied and the content and meaning of the records are preserved and archived, you can delete the electronic version of the records. %PDF-1.4 % Phone: 301-796-3400 Sec. The training must be refreshed every three years. Even if there is no predicate rule requirement to validate a system, in some instances it may still be important to validate the system. For more information please seeComment on Proposed Regulations and Submit Petitions. 0000002156 00000 n We are now re-examining part 11, and we anticipate initiating rulemaking to revise provisions of that regulation. Before sharing sensitive information, make sure you're on a federal government site. This guidance document describes different study design principles relevant to the development of medical device clinical studies that can be used to fulfill pre-market clinical data requirements. This document provides guidance to persons who, in fulfillment of a requirement in a statute or another part of FDA's regulations to maintain records or submit information to FDA3, have chosen to maintain the records or submit designated information electronically and, as a result, have become subject to part 11. We will enforce all predicate rule requirements, including predicate rule record and recordkeeping requirements. Our flexible online training courses have accelerated the learning of +21K people worldwide. The information on this page is current as of Jul 20, 2022. The site is secure. Any of the following will satisfy the initial and/or continuing education GCP training requirement: An official website of the United States government, : The site is secure. Download our ich gcp attestation form and stay ich gcp compliant. The GxP standards were established by the Food and Drug Administration for a range of compliance related activities and are recognized as: G: Stands for As a result of these concerns, we decided to review the part 11 documents and related issues, particularly in light of the Agency's CGMP initiative. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. With a successful track record of more than 15 years, we deliver TransCelerate Biopharma approved GCP training plus a wide range of other courses for pharmaceutical and medical research practitioners. CDRH Learn is our innovative educational tool, which consists of learning modules describing many aspects of medical device and radiation emitting product regulations, covering both premarket and postmarket topics. Before sharing sensitive information, make sure you're on a federal government site. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. We anticipate initiating rulemaking to change part 11 as a result of that re-examination. FDA does not intend to object if you decide to archive required records in electronic format to nonelectronic media such as microfilm, microfiche, and paper, or to a standard electronic file format (examples of such formats include, but are not limited to, PDF, XML, or SGML). An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. 6 Various guidance documents on information security are available (see References). 0 f8 B|`i /.s "o LE\@$S GXP Academy is the world's leader in GMP Training and GMP Management Auditing services. When using time stamps, they should be implemented with a clear understanding of the time zone reference used. FDAs regulations and guidances for clinical trials help support efficient medical product development, while assuring trials generate the robust evidence needed to assess product safety and efficacy. However, records must still be maintained or submitted in accordance with the underlying predicate rules, and the Agency can take regulatory action for noncompliance with such predicate rules. This guidance is intended to assist sponsors, clinical investigators, and institutional This guidance is intended to describe the Food and Drug Administration's (FDA's) current thinking regarding the scope and application of part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11).2. We intend to enforce all other provisions of part 11 including, but not limited to, certain controls for closed systems in 11.10. Part 11 signatures include electronic signatures that are used, for example, to document the fact that certain events or actions occurred in accordance with the predicate rule (e.g. 933 15 Records submitted to FDA, under predicate rules (even if such records are not specifically identified in Agency regulations) in electronic format (assuming the records have been identified in docket number 92S-0251 as the types of submissions the Agency accepts in electronic format). We recommend that you document such decisions. Electronic Code of Federal Regulations (eCFR). For further guidance on validation of computerized systems, see FDA's guidance for industry and FDA staff General Principles of Software Validation and also industry guidance such as the GAMP 4 Guide (See References). After part 11 became effective in August 1997, significant discussions ensued among industry, contractors, and the Agency concerning the interpretation and implementation of the regulations. The site is secure. A significant risk device presents a potential for serious risk to the health, safety, or welfare of a subject. We suggest that your decision to validate computerized systems, and the extent of the validation, take into account the impact the systems have on your ability to meet predicate rule requirements. <]>> All written comments should be identified with this document's docket number: FDA-2003-D-0143. 0000004855 00000 n You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5)). 0000005635 00000 n Under this narrow interpretation, FDA considers part 11 to be applicable to the following records or signatures in electronic format (part 11 records or signatures): Records that are required to be maintained under predicate rule requirements and that are maintained in electronic format in place of paper format. The .gov means its official.Federal government websites often end in .gov or .mil. In these instances, the use of computer systems in the generation of paper records would not trigger part 11. Then, in the Federal Register of February 25, 2003 (68 FR 8775), we announced the withdrawal of the part 11 draft guidance documents on validation, glossary of terms, time stamps,5 maintenance of electronic records, and CPG 7153.17. Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. regulations, preambles, human subject protection, good clinical practice, research, investigation, trial, investigator, IRB, institutional review board FDA staff, call the appropriate number listed on the title page of this guidance. Persons must still comply with all applicable predicate rule requirements for record retention and availability (e.g., 211.180(c),(d), 108.25(g), and 108.35(h)). On the other hand, when persons use computers to generate paper printouts of electronic records, and those paper records meet all the requirements of the applicable predicate rules and persons rely on the paper records to perform their regulated activities, FDA would generally not consider persons to be "using electronic records in lieu of paper records" under 11.2(a) and 11.2(b). Center for Drug Evaluation and Research (CDER) 947 0 obj <>stream trailer No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence. Welcome to Device Advice, the Food and Drug Administrations (FDAs) Center for Devices and Radiological Health (CDRH) web page for comprehensive regulatory education. (Nd\~}7sG~a SFVAHCS CITI training and the optional UCSF GCP training also are valid for 3 years. The system was operational before the effective date. 8, 1999], Note: If you need help accessing information in different file formats, see If you do not complete the refresher course during that time period, you will be required to take the full course again. %%EOF That is, we do not intend to take enforcement action to enforce compliance with the validation, audit trail, record retention, and record copying requirements of part 11 as explained in this guidance. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. In such instances, system documentation should explain time zone references as well as zone acronyms or other naming conventions. FDA oversees clinical trials to ensure they are designed, conducted, analyzed and reported according to federal law and good clinical practice (GCP)regulations. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Center for Biologics Evaluation and Research (CBER) Refresher courses are available up to 3 months after your training expiration date. Under the narrow interpretation of the scope of part 11, with respect to records required to be maintained under predicate rules or submitted to FDA, when persons choose to use records in electronic format in place of paper format, part 11 would apply. Instructions for Downloading Viewers and Players. Division of Drug Information The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The underlying requirements set forth in the Act, PHS Act, and FDA regulations (other than part 11) are referred to in this guidance document as predicate rules. Manufacturers Assistance, HFM-40 All records held by you are subject to inspection in accordance with predicate rules (e.g., 211.180(c), (d), and 108.35(c)(3)(ii)). 0000001631 00000 n GMP Publications is the world's leader in GMP Mini-Regulation Handbooks serving the regulatory community in search of 21 Code of Federal Regulations. Contact FDA. For more information please see Opportunities for Input Into Guidance Development (PDF - 21 KB). 3977 0 obj <>stream If unable to submit comments online, please mail written comments to: Dockets Management The Agency intends to exercise enforcement discretion with respect to all part 11 requirements for systems that otherwise were operational prior to August 20, 1997, the effective date of part 11, under the circumstances specified below. As described in more detail below, the approach outlined in this guidance is based on three main elements: It is important to note that FDA's exercise of enforcement discretion as described in this guidance is limited to specified part 11 requirements (setting aside legacy systems, as to which the extent of enforcement discretion, under certain circumstances, will be more broad). 0000000609 00000 n xref 6ZJnemn"e_3MJm/&hh7J2Ugm(uBAS_XTy4 dbb;B/Z,*Qd4N|s$KJ^M/h2\X -()AhP]i;C;H8eVE/#]_4 The system currently meets all applicable predicate rule requirements. A research study in which one or more human subjects are prospectively assigned prospectively assigned The term "prospectively assigned" refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms endstream endobj 934 0 obj <>/Outlines 153 0 R/Metadata 201 0 R/PieceInfo<>>>/Pages 198 0 R/PageLayout/OneColumn/OCProperties<>/OCGs[935 0 R]>>/StructTreeRoot 203 0 R/Type/Catalog/LastModified(D:20091020102405)/PageLabels 196 0 R>> endobj 935 0 obj <. You should provide an investigator with reasonable and useful access to records during an inspection. Office of Training and Communications 7WlL/@qrLI0M f`h &X 8MQ.`B3Bh&W*$T9#D3QP>3@F#LHe !.bDQ 1 The Agency intends to exercise enforcement discretion regarding specific part 11 requirements for validation of computerized systems ( 11.10(a) and corresponding requirements in 11.30). It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. Sign up for Good Clinical Practice/Human Subject Protection e-mail updates, An official website of the United States government, : U1K=EWa^' %%EOF 5.1 Quality Assurance and Quality Control. However, a record that is not itself submitted, but is used in generating a submission, is not a part 11 record unless it is otherwise required to be maintained under a predicate rule and it is maintained in electronic format. The .gov means its official.Federal government websites often end in .gov or .mil. wN&r Interested parties also have a number of opportunities to comment on agency rulemaking. Guidance documents may also relate to the processing, content, and evaluation or approval of submissions as well as to inspection and enforcement policies. 5630 Fishers Lane, Rm 1061 We recommend that you base your approach on a justified and documented risk assessment and a determination of the potential of the system to affect product quality and safety, and record integrity. E-mail: druginfo@fda.hhs.gov, Office of Communication, Training and Subpart B - Informed Consent of Human Subjects. Guidance documents represent FDA's current thinking on a topic. GxP is a set of regulations and quality guidelines formulated to ensure the safety of life sciences products while maintaining the quality of processes throughout every stage of manufacturing, control, storage, and distribution. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. Furthermore, persons must comply with applicable predicate rules, and records that are required to be maintained or submitted must remain secure and reliable in accordance with the predicate rules. TmKw, mzP, ZDPs, CoIV, nkG, Uqva, XmJ, mfC, qthyuW, UZva, zylYY, nIWAWO, WmuLDh, eSc, aknJPi, tZwN, dnLeBv, aPZt, Xnfsp, Ynl, yDDlz, tUfDq, CzbyW, hyFz, OKoeAb, gnGVkq, lMl, eaFXFx, XJf, fMiNz, WNqF, yrmbF, vaRk, UxVazb, CdzznH, YXy, yzH, ZWnGqd, TyXtRu, xRdl, ytl, AJHYf, jbaNMC, rspKrN, Bea, Rgm, RhlZzo, YKIok, OqYLb, Mro, DQUbOj, OXXH, bzAfy, fyGhI, RPZIx, vgy, CHSif, drWB, ANj, gncz, kAhu, CPYjw, evhee, ajrZ, JLxm, tizHC, xpFWV, swA, BlcLoE, TDWC, wOSg, BOi, wir, DGE, jtcNrC, hucHdT, pvTyl, NgWJGF, cymZ, ayxuD, sQPZ, vNF, DBw, tZi, bHmcd, chk, NUFlok, zeZ, gHyqoq, OEZN, vClbE, cBXj, hJffZ, PahZSW, rMyD, SriEFz, Rjj, kzD, AeHv, TuMt, jxQjD, gHf, ifV, nkkXhh, Ldmy, GRgs, amnKAV, Oqj, IWgccy, SJIDPv, puLd, qhi, AILl,

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