That is, the Agency may take your business practices into account in determining whether part 11 applies. The site is secure. 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. Manufacturers Assistance, HFM-40 These concerns have been raised particularly in the areas of part 11 requirements for validation, audit trails, record retention, record copying, and legacy systems. 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CPG 7153.17: Enforcement Policy: 21 CFR Part 11; Electronic Records; Electronic Signatures; and (3) published numerous draft guidance documents including the following: Throughout all of these communications, concerns have been raised that some interpretations of the part 11 requirements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. As a result, we want to clarify that the Agency intends to interpret the scope of part 11 narrowly. For more information please seeComment on Proposed Regulations and Submit Petitions. 6 Various guidance documents on information security are available (see References). 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. Before sharing sensitive information, make sure you're on a federal government site. Then, in the Federal Register of February 25, 2003 (68 FR 8775), we announced the withdrawal of the part 11 draft guidance documents on validation, glossary of terms, time stamps,5 maintenance of electronic records, and CPG 7153.17. 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). Protecting the rights, safety and welfare of people who participate in clinical trials is a critical aspect of the FDAs mission. 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. 0000001631 00000 n The .gov means its official.Federal government websites often end in .gov or .mil. Completing a Refresher Course Guidance documents describe FDAs interpretation of our policy on a regulatory issue (21 CFR 10.115(b)). The site is secure. If unable to submit comments online, please mail written comments to: Dockets Management 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. We are now re-examining part 11, and we anticipate initiating rulemaking to revise provisions of that regulation. 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. -Zi$WS*nVEB},BWtpq _Y +G6;Hm+-sAeA|3PM pPV&/e=E'$ a%Q;75i+-[f Center for Veterinary Medicine (CVM) Our flexible online training courses have accelerated the learning of +21K people worldwide. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. 1 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. Division of Drug Information limiting system access to authorized individuals, determination that persons who develop, maintain, or use electronic systems have the education, training, and experience to perform their assigned tasks, establishment of and adherence to written policies that hold individuals accountable for actions initiated under their electronic signatures, appropriate controls over systems documentation, controls for open systems corresponding to controls for closed systems bulleted above ( 11.30), requirements related to electronic signatures (e.g., 11.50, 11.70, 11.100, 11.200, and 11.300). xref Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations. Silver Spring, MD 20993 As mentioned previously, part 11 remains in effect during this re-examination period. For example, if a record is required to be maintained under a predicate rule and you use a computer to generate a paper printout of the electronic records, but you nonetheless rely on the electronic record to perform regulated activities, the Agency may consider you to be using the electronic record instead of the paper record. Regulations regarding commercially distributed analyte specific reagents (ASRs) (21 CFR 809.10(e), 809.30, and 864.4020), and role/responsibilities of manuf. Interested parties have a number of opportunities to provide input into guidance development. Fax: 301-847-8714 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). In these instances, the use of computer systems in the generation of paper records would not trigger part 11. 2BeDr@`Z 6.ai`&&#\ 6 !P&38in A%3ee`??r3mLn3tWcd^p]k ,e/t#B@ h@ These regulations, which apply to all FDA program areas, were intended to permit the widest possible use of electronic technology, compatible with FDA's responsibility to protect the public health. 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. 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. 0 0000005378 00000 n regulations, preambles, human subject protection, good clinical practice, research, investigation, trial, investigator, IRB, institutional review board 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). The .gov means its official.Federal government websites often end in .gov or .mil. 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. 3955 0 obj <> endobj 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. FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. 7 In this guidance document, we use the term legacy system to describe systems already in operation before the effective date of part 11. endstream endobj 946 0 obj <>/Size 933/Type/XRef>>stream The .gov means its official.Federal government websites often end in .gov or .mil. Search for officialFDA guidance documents and other regulatory guidance. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. IyD hb```,l@Y8& trailer You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. We had decided we wanted to minimize industry time spent reviewing and commenting on the draft guidance when that draft guidance may no longer represent our approach under the CGMP initiative. 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. %%EOF Center for Biologics Evaluation and Research (CBER) 0000001432 00000 n 933 0 obj <> endobj A locked padlock) or https:// means you've safely connected to the .gov website. Interested parties also have a number of opportunities to comment on agency rulemaking. 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. Contact FDA. 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. Phone: 301-796-3400 The training must be refreshed every three years. 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. 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). We anticipate initiating rulemaking to change part 11 as a result of that re-examination. 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. The training must be refreshed every three years. Before sharing sensitive information, make sure you're on a federal government site. 0000005635 00000 n We do not intend to re-issue these draft guidance documents or the CPG. 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. 0 f8 B|`i /.s A significant risk device presents a potential for serious risk to the health, safety, or welfare of a subject. Some FDA guidance documents on this list are indicated as open for comment. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. You should also consider the impact those systems might have on the accuracy, reliability, integrity, availability, and authenticity of required records and signatures. Search for FDA Guidance Documents, Recalls, Market Withdrawals and Safety Alerts, Search General and Cross-Cutting Topics Guidance Documents, Part 11, Electronic Records; Electronic Signatures - Scope and Application, Approach to Specific Part 11 Requirements. 0000002946 00000 n We intend to enforce all other provisions of part 11 including, but not limited to, certain controls for closed systems in 11.10. 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. 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. FDA proposed to revise the requirements for submitting written IND safety reports, under Sec. 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. endstream endobj 3956 0 obj <. Individuals engaged in the conduct of a clinical trial (per the NIH definition) must complete a Good Clinical Practice (GCP) training. Except as provided in 50.23 and 50.24, no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized 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. 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 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. Download our ich gcp attestation form and stay ich gcp compliant. ^23co;h E%|]V)Z^}z\e A}LM,`w8@ca`KK O( 2P&Ef2,FA .' 3968 0 obj <>/Filter/FlateDecode/ID[]/Index[3955 23]/Info 3954 0 R/Length 81/Prev 704866/Root 3956 0 R/Size 3978/Type/XRef/W[1 3 1]>>stream 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). FDA oversees clinical trials to ensure they are designed, conducted, analyzed and reported according to federal law and good clinical practice (GCP)regulations. 0000002419 00000 n Food and Drug Administration We suggest that you apply appropriate controls based on such an assessment. [46 FR 8951, Jan. 27, 1981, as amended at 64 FR 10942, Mar. Refresher courses are available up to 3 months after your training expiration date. 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)). za][LQ %@Hsq]t]% 60073 QA{,'F'K +*TAt &8/ ["TUD09k&ofL+Ds cL0Ha` @19*tL3o8uUh3J\O,g7"}.-= xm{Nei;];CKy4Sb`\ NIH Definition of a Clinical Trial. Part 11 will be interpreted narrowly; we are now clarifying that fewer records will be considered subject to part 11. The agency works to ensure its GCP policies continue to facilitate new approaches to generating quality clinical evidence. Appropriate delegation is primarily an issue for tasks considered to be clinical or medical in 0000003274 00000 n 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). This feature is provided to give a convenient way to search for all FDA guidance documents from a single location. 1 This guidance has been prepared by the Office of Compliance in the Center for Drug Evaluation and Research (CDER) in consultation with the other Agency centers and the Office of Regulatory Affairs at the Food and Drug Administration. When using time stamps, they should be implemented with a clear understanding of the time zone reference used. Instructions for Downloading Viewers and Players. 3 These requirements include, for example, certain provisions of the Current Good Manufacturing Practice regulations (21 CFR Part 211), the Quality System regulation (21 CFR Part 820), and the Good Laboratory Practice for Nonclinical Laboratory Studies regulations (21 CFR Part 58). Good Clinical Practice Training. Sign up for Good Clinical Practice/Human Subject Protection e-mail updates, An official website of the United States government, : 0 10903 New Hampshire Ave Office of Training and Communications 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. In each case, we recommend that the copying process used produces copies that preserve the content and meaning of the record. 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 addition, paper and electronic record and signature components can co-exist (i.e., a hybrid8 situation) as long as predicate rule requirements are met and the content and meaning of those records are preserved. Sec. startxref In some cases, actual business practices may dictate whether you are using electronic records instead of paper records under 11.2(a). We recommend that you document such decisions. Welcome to Device Advice, the Food and Drug Administrations (FDAs) Center for Devices and Radiological Health (CDRH) web page for comprehensive regulatory education. 0000001967 00000 n We believe that some of those broad interpretations could lead to unnecessary controls and costs and could discourage innovation and technological advances without providing added benefit to the public health. 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 The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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). 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. Electronic Code of Federal Regulations (eCFR). Although persons must still comply with all applicable predicate rule requirements for validation (e.g., 21 CFR 820.70(i)), this guidance should not be read to impose any additional requirements for validation. xb```b````_Y8 training, good clinical practice, research human subject protection, informed consent, institutional review board, IRB, sponsor, trial, study, investigator 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). This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. 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. WO51, Room 2201 &*|m This means that the Agency does not intend to take enforcement action to enforce compliance with any part 11 requirements if all the following criteria are met for a specific system: If a system has been changed since August 20, 1997, and if the changes would prevent the system from meeting predicate rule requirements, Part 11 controls should be applied to Part 11 records and signatures pursuant to the enforcement policy expressed in this guidance. If you do not complete the refresher course during that time period, you will be required to take the full course again. Office of Training and Communications Division of Drug Information Center for Drug Evaluation and Research (CDER) WO51, Room 2201 10903 New Hampshire Ave The system was operational before the effective date. Note that part 11 remains in effect and that this exercise of enforcement discretion applies only as identified in this guidance. 50.20 General requirements for informed consent. 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. We recommend that you determine, based on the predicate rules, whether specific records are part 11 records. education, training, and experience (and state licensure where relevant) to perform the delegated task. 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). endstream endobj startxref 0000004611 00000 n Electronic signatures that are intended to be the equivalent of handwritten signatures, initials, and other general signings required by predicate rules. 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Before sharing sensitive information, make sure you're on a federal government site. Language Assistance Available: Espaol | | Ting Vit | | Tagalog | | | Kreyl Ayisyen | Franais | Polski | Portugus | Italiano | Deutsch | | | English, The information on this page is current as of. We understand that there is some confusion about the scope of part 11. X$Drn1 jb }@"@}D>U0 However, records must still be maintained or submitted in accordance with the underlying predicate rules, and the Agency can take regulatory action for noncompliance with such predicate rules. wN&r For more information please see Opportunities for Input Into Guidance Development (PDF - 21 KB). 7WlL/@qrLI0M f`h &X 8MQ.`B3Bh&W*$T9#D3QP>3@F#LHe !.bDQ FDA staff, call the appropriate number listed on the title page of this guidance. 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. 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. These documents usually discuss more specific products or issues that relate to the design, production, labeling, promotion, manufacturing, and testing of regulated products. Center for Drug Evaluation and Research (CDER) 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. 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. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. An official website of the United States government, : %%EOF 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. 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 Even if there is no predicate rule requirement to validate a system, in some instances it may still be important to validate the system. In such instances, system documentation should explain time zone references as well as zone acronyms or other naming conventions. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. You should provide an investigator with reasonable and useful access to records during an inspection. 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. 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. Device Advice, FDA-CDRH's webpage for comprehensive regulatory education. FDA Basics for Industry, Recalls, Market Withdrawals and Safety Alerts, Product Application and Petition Review Process, For Trade and Industry Groups: Requesting Cross-Agency Speakers From FDA, Opportunities for Input Into Guidance Development (PDF - 21 KB), Comment on Proposed Regulations and Submit Petitions, Center for Veterinary Medicine Guidance Documents Under Development, Center for Devices and Radiological Health 2018 (FY 2015) Proposed Guidance Development and Focused Retrospective Review of Final Guidance, Guidance Agenda: New & RevisedDraft Guidances CDER is Planning to Publish During Calendar Year 2018 (PDF - 46KB), Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2022, Recent Draft Medical Device Guidance Documents, Recent Vaccines, Blood, Biologics Guidances, International Council forHarmonisation (ICH), Veterinary International Conference on Harmonization (VICH), Medical Devicesand Radiation-Emitting Products. 8, 1999], Note: If you need help accessing information in different file formats, see They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. This guidance explains that we will narrowly interpret the scope of part 11. Except as provided in 50.23 and 50.24, no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. 0000004855 00000 n refers to the regulations under 21 CFR 812 that apply to clinical investigations. Some have understood the scope of part 11 to be very broad. 50.20 General requirements for informed consent. SFVAHCS CITI training and the optional UCSF GCP training also are valid for 3 years. Rockville, MD 20852. 6ZJnemn"e_3MJm/&hh7J2Ugm(uBAS_XTy4 dbb;B/Z,*Qd4N|s$KJ^M/h2\X -()AhP]i;C;H8eVE/#]_4 If you have the ability to search, sort, or trend part 11 records, copies given to the Agency should provide the same capability if it is reasonable and technically feasible. Phone: the Voice Information System at 800-835-4709 or 301-827-1800, Communications Staff (HFV-12), 4 See Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach; A Science and Risk-Based Approach to Product Quality Regulation Incorporating an Integrated Quality Systems Approach . xbb8f;1Gc4>Fh|(` b CCRPS provides accredited, industry-recognized on-demand advanced ICH GCP course covering ich gcp guidelines, ich gcp e6 r2, ich gcp sae reporting, and other updated ich gcp guidelines through ich gcp training transcelerate. 0000002156 00000 n CDRH Learn is our innovative educational tool, which consists of learning modules describing many aspects of medical device and radiation emitting product regulations, covering both premarket and postmarket topics. (Tel) 240-276-9300, Division of Small Manufacturers, International, and ConsumerAssistance (HFZ-220) Before sharing sensitive information, make sure you're on a federal government site. Guidance documents represent FDA's current thinking on a topic. .rT$c` "qacZ=2{N.Y.Pf/gV4*TR5n_trO4r4mn~> The site is secure. 1 (800) 638-2041 (301) 796-7100 DICE@fda.hhs.gov. 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. For instance, validation would not be important for a word processor used only to generate SOPs. 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, : 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. The information on this page is current as of Jul 20, 2022. qMqYGjzx>dKf9^J]i{U(f|(0m It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. GXP Academy is the world's leader in GMP Training and GMP Management Auditing services. You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5)). 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. FDA considers direct advertising for study subjects to be the start of the informed consent and subject selection process. Sec. CDRH hosts webinars and calls to educate stakeholders on guidances and other topics related to the regulation of medical devices and radiation-emitting products. 0000000016 00000 n "o LE\@$S 5630 Fishers Lane, Rm 1061 We received valuable public comments on these draft guidances, and we plan to use that information to help with future decision-making with respect to part 11. Persons must still comply with all predicate rule requirements, and the records themselves and any copies of the required records should preserve their content and meaning. The Agency intends to exercise enforcement discretion with regard to specific part 11 requirements for generating copies of records ( 11.10 (b) and any corresponding requirement in 11.30). The .gov means its official.Federal government websites often end in .gov or .mil. Manufacturers Assistance Phone Number: 800-638-2041 or 301-796-7100, Center for Food Safety and Applied Nutrition (CFSAN). This guidance is intended to assist sponsors, clinical investigators, and institutional The system met all applicable predicate rule requirements before the effective date. The system currently meets all applicable predicate rule requirements. %PDF-1.6 % Division of Industry and Consumer Education, An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Device Advice: Comprehensive Regulatory Assistance, Guidance Documents (Medical Devices and Radiation-Emitting Products), Data Standards and Terminology Standards for Information Submitted to CDRH, Reprocessing of Reusable Medical Devices: Information for Manufacturers, Unique Device Identification System (UDI System), Contact Us Division of Industry and Consumer Education (DICE), COVID-19 (Coronavirus) and Medical Devices. Significant Risk Device. 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. GMP Publications is the world's leader in GMP Mini-Regulation Handbooks serving the regulatory community in search of 21 Code of Federal Regulations. This web page contains information about such events, both past and upcoming. 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). 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. FDA regulations [21 CFR parts 50 and 56] apply to research involving products regulated by FDA - federal funds and/or support do not need to be involved for the FDA regulations to apply. Good Clinical Practice Training. 5.1 Quality Assurance and Quality Control. All written comments should be identified with this document's docket number: FDA-2003-D-0143. 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). While the re-examination of part 11 is under way, we intend to exercise enforcement discretion with respect to certain part 11 requirements. 3977 0 obj <>stream Instructions for Downloading Viewers and Players. 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. Share sensitive information only on official, secure websites. 0000004083 00000 n k The site is secure. Individuals engaged in the conduct of a clinical trial (per the NIH definition) must complete a Good Clinical Practice (GCP) training. 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). 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. Subpart B - Informed Consent of Human Subjects. (Nd\~}7sG~a 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. We recommend that you document this decision (e.g., in a Standard Operating Procedure (SOP), or specification document). Audit trails can be particularly appropriate when users are expected to create, modify, or delete regulated records during normal operation. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. 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. 0000000609 00000 n You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. 947 0 obj <>stream Guidance documents may also relate to the processing, content, and evaluation or approval of submissions as well as to inspection and enforcement policies. E-mail: druginfo@fda.hhs.gov, Office of Communication, Training and For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). 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). 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. 933 15 Any of the following will satisfy the initial and/or continuing education GCP training requirement: 0000003196 00000 n U1K=EWa^' hbbd```b`` 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 <. 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