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What is a waiver of informed consent?
Waiver of Documentation of Informed Consent (45 CFR 46.117)

This means that the study team must provide a subject with the required consent information, but the study team is not required to obtain the subject's signature on the informed consent document.
What is a waiver in clinical trials?
A Protocol Waiver may be defined as the sponsor approval for a prospective protocol deviation. Such deviations can often involve (but may not be limited to) the active recruitment to a study of one or more participants who do not meet the inclusion/exclusion criteria as detailed in the study protocol.
What is the criteria for waiver of documentation of informed consent?
For research that is FDA-regulated, a waiver of documentation of consent may be granted only: When the research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside the research context.
What is the difference between a waiver and informed consent?
A waiver is legal document releasing or relinquishing a known right, claim, or privilege. In this context, it is the relinquishment to pursue a claim in a certain set of defined circumstances. Informed consent is a written acknowledgement that a participant understands the risks inherent in a particular activity.
Inform consent:- A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate

Inform consent Waiver:- It is a process in which informed consent is not obtained from subjects, or that eliminates or alters some (or all) of the elements of informed consent as set forth in Federal regulations (45 CFR 46.116d)
The IRB must ensure that the following 4 criteria are met prior to approving a waiver or alteration of consent:
The research poses no more than minimal risk to subjects
The research does not adversely affect the rights and welfare
The research not practicable without the waiver
Whenever appropriate. The subject will be provided with pertinent information after participation
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Post Graduate Diploma in Clinical Research. Pharmacovigilance, Clinical Trials, Clinical Data Management, Clinical Operation, Medical writing.
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IC Waiver in Clinical Trials I Clinical Research.pptx What is a waiver of informed consent? Waiver of Documentation of Informed Consent (45 CFR 46.117) This means that the study team must provide a subject with th…

What are Good Documentation Practices?
In the context of these guidelines, good documentation practices are those measures that collectively and individually ensure documentation, whether paper or electronic, is secure, attributable, legible, traceable, permanent, contemporaneously recorded, original and accurate.
Inform Consent form
Investigator’s brochure
Case report form
Clinical study protocol
Clinical study reports
Trial master file
Laboratory reports
Standard operating procedure

General Information

Maintain records of all data and observations pertinent to the research subject. These records should be identifiable to a particular participant.
Remember that source documents are where the information is first recorded.
All data must be verifiable.
Study documentation should be able to recreate the study for any reviewer.
Apply the ALCOA acronym for proper technique of documentation:
Attributable – Can you tell who wrote and/or did this
Legible – Can it be read?
Contemporaneous- – Is the data current, and in the correct time frame? The notation, signature and date should occur at the same time.
Original – Has the data been altered?
Accurate – Are there conflicting data elsewhere? Content should precisely reflect the event.
Use a signed Note to File to explain any discrepancies, missing or incomplete data.

Standards

The same standards maintained for medical documentation should be followed for research documentation
All documents require 2 identifiers on each page.
All entries are to be signed and dated in real time.
Error corrections are made by drawing a single line through the incorrect entry, initial and date.
Never obliterate entries that require correction.
Subject records need to be secure but accessible.
Do not alter past-dated notes by writing alongside or adding to prior entries. Updates may be made through addenda.
Use dark ink, do not use pencil.
Never use whiteout.

Questionnaires

Documentation must reflect who completed the questionnaire, in compliance with the protocol.
For questionnaires completed by staff, a note should reflect how the information was obtained ie: direct interview with participant, phone call, chart abstraction.
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Post Graduate Diploma in Clinical Research. Pharmacovigilance, Clinical Trials, Clinical Data Management, Clinical Operation, Medical writing.

Good Documentation Practices Examples in Clinical Trials I Clinical R… What are Good Documentation Practices? In the context of these guidelines, good documentation practices are those measures that collectively and individually e…

What is FDA Form 3454 for?
Form FDA 3454, or the Financial Certification or Disclosure Statement, is used to submit information regarding clinical investigators who participated in the clinical studies. If no clinical studies were performed, simply state: “no clinical studies were performed to test this device.”
Form 3454 or The Financial Certification or Disclosure Statement is used to submit information regarding clinical investigators who participated in the clinical studies.
Form 3454 contains in the 21 CFR Part 54
Applicable since 1999
The Financial Disclosure by Clinical Investigators regulation (21 CFR part 54) requires applicants who submit a marketing application for a drug, biological product or device to submit certain information concerning the compensation to, and financial interests and arrangements of, any clinical investigator conducting clinical studies covered by the regulation.
What is the Purpose?
FDA evaluates clinical studies submitted in marketing applications, required by law, for new human drugs and biological products and marketing applications and reclassification petitions for medical devices.
FDA may consider clinical studies inadequate & data inadequate if steps have not been taken to minimize bias.
“Potential source of bias in clinical studies is a financial interest of the clinical investigator in the outcome of the study”. Siro Clinical Research Institute. www.siroinstitute.com
Post Graduate Diploma in Clinical Research. Pharmacovigilance, Clinical Trials, Clinical Data Management, Clinical Operation, Medical writing.

Form_FDA_3454 in Clinical Trials I Clinical Research.pptx What is FDA Form 3454 for? Form FDA 3454, or the Financial Certification or Disclosure Statement, is used to submit information regarding clinical investigator…

What Is IP?
IP/ IMP – Investigational Medical Product

An investigational product refers to a preventative (vaccine), a therapeutic (drug or biologic), device, diagnostic, or palliative used in a clinical trial.
What is IP manufacturing?
IP Manufacturing responsibility lies with the sponsor with any applicable GMP.
Any changes in the investigational or comparator product during the course of clinical development – additional studies need to be check for formulated product whether these changes would significantly alter the pharmacokinetic profile of the product.
What is Labeling?
The IP label contains information on :
Composition
Storage
Requirements, expiration date (if applicable), etc.
Expired and/or un-labelled IP must be quarantined and not to be dispensed.
Explain expiration and retest dates to the subject.
The statement: "For clinical research use only" or similar wording
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Flow of IP From Manufacturing Facility To Patient in Clinical Trials … What Is IP? IP/ IMP – Investigational Medical Product An investigational product refers to a preventative (vaccine), a therape​utic (drug or biologic), devi…

Siro Clinical Research Institute | LinkedIn Siro Clinical Research Institute | 1,121 followers on LinkedIn. A SIRO Initiative | SCRI - Siro Clinical Research Institute is a Siro initiative for Training in clinical research. Siro Clinpharm, India's first and oldest CRO, was Incorporated in 1996. SIRO Clinpharm Private Limited is a Clinical...

A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having being informed of all aspects of the trial that are relevant to the subjects decision to participate.
Informed consent is documented by means of written, signed and dated informed consent form.
The goal of the informed consent process is to provide people with sufficient information so that they can make informed choices about whether to being or continue participation in clinical research.
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Essential elements of P*S and ICF in Clinical Trials I Clinical Resea… A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having being informed of all aspects of th…

Essential documents are those documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced.
Essential documents serve to demonstrate compliance with the standards of Good Clinical Practice (GCP) and with all applicable regulatory requirements. These document files may be audited by the sponsor and regulatory authorities to confirm the validity of the clinical research conduct and integrity of the data.
The essential documents for clinical trials are the following: Investigator's Brochure. Clinical Study Protocol. Subject Information and Informed Consent Form.
Essential documents are commonly referred to as regulatory documents. ICH GCP guidance defines essential documents as “those documents which individually and collectively permit evaluation of the conduct of the clinical trial and the quality of the data produced.
The most important purpose of source documentation in a clinical trial is to reconstruct the trial as it happened. It should enable an independent observer to reconfirm the data. Documentation should be such that it is able to provide audit trail to permit investigation if and when required.
Siro Clinical Research Institute
Siro Clinpharm initiative
www.siroinstitute.com
Post Graduate Diploma in Clinical Research. Pharmacovigilance, Clinical Trials, Clinical Data Management, Clinical Operation, Medical writing.

Essential Document in Clinical Research I Clinical Trials I Clinical … Essential documents are those documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced. …

21 CFR Part 11, commonly referred to as “Part 11” is a set of rules that specifies what is required for electronic records and signatures. The regulatory framework outlines the management of records in Electronic Quality Management Systems for Life Science and other FDA-regulated industries.
Why is it called 21 CFR Part 11?
What is 21 CFR Part 11? CFR stands for “Code of Federal Regulation.” 21 CFR Part 11, in particular, details the criteria under which electronic records and signatures are considered to be trustworthy and equivalent to paper records.
What are the 21 CFR rules?
21 CFR Rules set out guidelines on the usages and management of electronic records as well as electronic signatures. As such, as the user of electronic data records, you are guided by 21 CFR rules so that you can have optimal benefits from the data and also act in integrity.
(a) The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.

(b) This part applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations. This part also applies to electronic records submitted to the agency under requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, even if such records are not specifically identified in agency regulations. However, this part does not apply to paper records that are, or have been, transmitted by electronic means.

(c) Where electronic signatures and their associated electronic records meet the requirements of this part, the agency will consider the electronic signatures to be equivalent to full handwritten signatures, initials, and other general signings as required by agency regulations, unless specifically excepted by regulation(s) effective on or after August 20, 1997.
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21 CFR Part 11 Code of Federal Regulations.pptx 21 CFR Part 11, commonly referred to as “Part 11” is a set of rules that specifies what is required for electronic records and signatures. The regulatory frame…

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