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Documentation clinical trial

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By:
Ankit SharmA
M.Pharma 2nd sem
Pharmacology
Bhupal Noble University,Udaipur
Clinical Trials : Introduction
 The International Conference on Harmonization defines a
clinical trials as, Any investigation in humans subjects
intended to discover or verify the clinical, pharmacological
and/or other pharmacodynamic effects of an investigational
product, and/or to identify any ADR to an investigational
drugs, and/or to study ADME of drug with the objective of
ascertaining the safety and efficacy .
 This is also termed as randomized control trial .
 Clinical trials are a set of procedures in medical
research conducted to allow safety and efficacy data to be
collected for health interventions.
Bhupal Noble University,Udaipur
Different Types of
Clinical Trials
Treatment trials - test new treatment, new combinations of drugs,
or new approaches to surgery or radiation therapy (for people with a
particular disease).
Prevention trials - look for better ways to prevent disease in people
who have never had the disease or to prevent a disease from
returning. These approaches may include medicines, vitamins,
vaccines, minerals or lifestyle changes.
Screening trials – test the best way to detect certain diseases or
health conditions.
Quality of life trials ( or supportive care trials) – explore ways to
improve comfort and the quality of life for individuals with a chronic
illness
Bhupal Noble University,Udaipur
Different Phases of
Clinical Trials
Clinical trials are conducted in phases. The trials at each phase have a different
purpose and help scientists answer different questions:
 In Phase I trials, researchers test a new drug or treatment in a small group of
healthy people ( 20 -50) for the first time to evaluate its safety, determine a safe
dosage range.
 In Phase II trials, the study drug or treatment is given to a selected group of
patients (100 – 300) to see if it is effective and to further evaluate its safety.
 In Phase III trials, the study drug or treatment is given to a large group of patients
( 1000 – 3000) to confirm its effectiveness, monitor side effects, compare it to
commonly used treatments, and collect information that will allow the drug or
treatment to be used safely.
 In Phase IV trials, post marketing studies delineate additional information
including the drug’s risks, benefits and optimal use.Bhupal Noble University,Udaipur
The Clinical Trial Application
 Covering letter
 Completed Application form (CTF1)
 Cover sheet
 Checklist
 Final version of the Clinical Trial Protocol
 Patient Information leaflet and Informed Consent form
 Investigators Brochure and/or Package Insert
 Signed investigator(s) CV(s) in required format
 Signed declaration by Principal investigator(s)
 Signed joint declaration by Sponsor/National Principal investigator
 Signed declaration by Co- or Sub-investigators
 Signed declaration by regional monitor and/or study coordinator
 Indemnity and Insurance Certificate and/or
 Proof of Malpractice insurance of trialist(s)
 Ethics Committee(s) approval or
 Copy of letter submitted to Ethics Committee(s)
 Electronic copies to be submitted in Microsoft Word format
 Financial declaration by Sponsor and Principle investigator
Bhupal Noble University,Udaipur
Clinical Trial Documentation:
Introduction
 All records, in any form (including, but not limited to,
written, electronic, magnetic, and optical records, and
scans, x-rays, and electrocardiograms) that describe or
record the methods, conduct and/or results of a trial, the
factors affecting a trial and the actions taken.
 Such a record is known as, “Document” and process is
“Documentation”
 The trial documents are both a resource and an outcome;
they are the outcome of the study and a resource for the
regulators.
Bhupal Noble University,Udaipur

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Documentation clinical trial

  • 1. By: Ankit SharmA M.Pharma 2nd sem Pharmacology Bhupal Noble University,Udaipur
  • 2. Clinical Trials : Introduction  The International Conference on Harmonization defines a clinical trials as, Any investigation in humans subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product, and/or to identify any ADR to an investigational drugs, and/or to study ADME of drug with the objective of ascertaining the safety and efficacy .  This is also termed as randomized control trial .  Clinical trials are a set of procedures in medical research conducted to allow safety and efficacy data to be collected for health interventions. Bhupal Noble University,Udaipur
  • 3. Different Types of Clinical Trials Treatment trials - test new treatment, new combinations of drugs, or new approaches to surgery or radiation therapy (for people with a particular disease). Prevention trials - look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals or lifestyle changes. Screening trials – test the best way to detect certain diseases or health conditions. Quality of life trials ( or supportive care trials) – explore ways to improve comfort and the quality of life for individuals with a chronic illness Bhupal Noble University,Udaipur
  • 4. Different Phases of Clinical Trials Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:  In Phase I trials, researchers test a new drug or treatment in a small group of healthy people ( 20 -50) for the first time to evaluate its safety, determine a safe dosage range.  In Phase II trials, the study drug or treatment is given to a selected group of patients (100 – 300) to see if it is effective and to further evaluate its safety.  In Phase III trials, the study drug or treatment is given to a large group of patients ( 1000 – 3000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.  In Phase IV trials, post marketing studies delineate additional information including the drug’s risks, benefits and optimal use.Bhupal Noble University,Udaipur
  • 5. The Clinical Trial Application  Covering letter  Completed Application form (CTF1)  Cover sheet  Checklist  Final version of the Clinical Trial Protocol  Patient Information leaflet and Informed Consent form  Investigators Brochure and/or Package Insert  Signed investigator(s) CV(s) in required format  Signed declaration by Principal investigator(s)  Signed joint declaration by Sponsor/National Principal investigator  Signed declaration by Co- or Sub-investigators  Signed declaration by regional monitor and/or study coordinator  Indemnity and Insurance Certificate and/or  Proof of Malpractice insurance of trialist(s)  Ethics Committee(s) approval or  Copy of letter submitted to Ethics Committee(s)  Electronic copies to be submitted in Microsoft Word format  Financial declaration by Sponsor and Principle investigator Bhupal Noble University,Udaipur
  • 6. Clinical Trial Documentation: Introduction  All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct and/or results of a trial, the factors affecting a trial and the actions taken.  Such a record is known as, “Document” and process is “Documentation”  The trial documents are both a resource and an outcome; they are the outcome of the study and a resource for the regulators. Bhupal Noble University,Udaipur
  • 7. Trial Master File (TMF)  Guideline E6 states that trail master file should be established at the beginning of the trail,both at the investigator/institution site and at the sponsors office.  A final close-out of a trail only be done when the monitor has reviewed both the investigator/institution and sponsor files and confirm that all necessary documents are in the appropriate files .  The file maintained at the site is often called, The Site Master File .  The file is generally the responsibility of a designated member of the investigating team at the site of the monitor at the sponsors office. Bhupal Noble University,Udaipur
  • 8. Source Documents  Original documents, data, and records.  These documents are generally confidential and should not be made available to all and sundry.  After the end of the trial period, these docs must be archived for a very long time.  ICH guidelines E6 states, Essential documents should be retained until at least 2 years after last approval of a marketing application in an ICH region .  Investigator should ask for a written consent of sponsor to destroy the documents and this written permission stored forever. Bhupal Noble University,Udaipur
  • 9. Essential Documents  Essential Documents are those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced  These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements.  Essential Documents also serve a number of other important purposes.  These documents are also the ones which are usually audited by the sponsor's independent audit function and inspected by the regulatory authority(ies) as part of the process to confirm the validity of the trial conduct and the integrity of data collected. Bhupal Noble University,Udaipur
  • 10. Essential Documents For Clinical Trials :The Essential Documents For Clinical Trials are as Follow:  Investigator's Brochure  Clinical Study Protocol  Case Report Form (CRF)  Informed Consent Form  Clinical Study Reports Bhupal Noble University,Udaipur
  • 11. INVESTIGATOR'S BROCHURE (IB):  List of Abbreviations  Contents & Summary  Introduction provides the chemical name (and generic and trade names, if approved) of the investigational product.  Physical, chemical and pharmaceutical properties and formulation of the medicinal product.  Non-clinical studies & Clinical Studies and their resulkts.  Conclusions and Guidance for the Investigator  References (at the end of each section)  NOTE: The Investigator's Brochure should be reviewed at least annually and revised as necessary in compliance with a standard procedures established by drug development company. Bhupal Noble University,Udaipur
  • 12. CASE RECORD/REPORT FORM (CRF)  CRF is a paper or electronic document designed to record all the information for an individual study subject required by the Study protocol. All CRF's should include the following data:  Study title and number;  Investigator's name;  Study subject/patient ID (number and initials);  Inclusion / exclusion criteria;  Demographic data;  Detailed description of dosage regimens of investigational drug;  Concomitant treatment;  Adverse events (side effects and intercurrent diseases);  Conclusion on subject's health;  Investigator's signature and date. Bhupal Noble University,Udaipur
  • 13. Clinical Study Protocols  The Guideline ICH E6 defines the protocol as, A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial.  The protocol usually also gives the background and rationale for the trail but these could be provided in other protocol refrenced documents also.  Appendix II (6) of schedule Y to Drugs and Cosmetic rules(2005) implies that all clinical trails to be carried out as per the conditions laid down in the Decleration of Helsinki (DOH). Bhupal Noble University,Udaipur
  • 14. Decleration of Helsinki  “The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol”.  “Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and on adequate laboratory and, where appropriate animal experimentation.”  “Every medical research project involving human subjects should be preceded by careful assessment of predictable risks and burdens in comparison with foreseeable benefits to the subject or to others”. Bhupal Noble University,Udaipur
  • 15. Decleration of Helsinki contd.  “In medical research on human subjects, considerations related to the well-being of the human subject should take precedence over the interests of science and society.”  “In medical research on human subjects, considerations related to the well-being of the human subject should take precedence over the interests of science and society”  “The protocol should be submitted for consideration, comment, guidance, and where appropriate, approval to a specially appointed ethical review committee, which must be independent of the investigator, the sponsor, or any other kind of undue influence. This independent committee should be in conformity with the laws and regulations of the country in which the research experiment is performed” Bhupal Noble University,Udaipur
  • 16. Decleration of Helsinki contd.  “The subjects must be volunteers and informed participants in the research project.”  “Both authors and publishers have ethical obligations. In publication of the results of research, the investigators are obliged to preserve the accuracy of the results. Negative as well as positive results should be published or otherwise publicly available”.  “It is the duty of the physician in medical research to protect the life, health, privacy, and dignity of the human subject.”  Note: “Reports of experimentation not in accordance with the principles laid down in this Declaration, should not be accepted for publication”. Bhupal Noble University,Udaipur
  • 17. Parts of Protocol  Introduction/Abstract  Objectives  Background/Rationale  Eligibility criteria  Study design/methods (including drug/device info)  Safety/adverse events  Regulatory guidance  Statistical section (including analysis & monitoring)  Human subjects protection/informed consent Bhupal Noble University,Udaipur
  • 18. CASE RECORD/REPORT FORM (CRF)  CRF is a paper or electronic document designed to record all the information for an individual study subject required by the Study protocol. :All CRF's should include the following data:  Study title and number;  Investigator's name;  Study subject/patient ID (number and initials);  Inclusion / exclusion criteria;  Demographic data;  Detailed description of dosage regimens of investigational drug;  Concomitant treatment;  Adverse events (side effects and intercurrent diseases);  Conclusion on subject's health;  Investigator's signature and date. Bhupal Noble University,Udaipur
  • 19. INFORMED CONSENT  Informed consent is a process by which a subject voluntary confirms his/her willingness to participate in one or another clinical trial, after having been informed of all aspects of the study.  Informed consent should be documented by means of a written, signed and dated Informed Consent Form (ICF). :The Subject Should be Informed of the Following:  the purposes of the trial;  the methods of the trial;  the study drug(s) and treatment regimens;  available alternative treatment(s);  the potential risks and benefits, and possible discomforts. Bhupal Noble University,Udaipur
  • 20. Monitoring in Clinical Trial PURPOSES: SELECTION& QUALIFICATIONS  The rights and well-being of human subjects are protected.  The reported trial data are accurate, complete, and verifiable from source documents.  The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement  Monitors should be appointed by the sponsor.  Monitors should be appropriately trained, and should have the scientific and/or clinical knowledge needed to monitor the trial adequately.  Monitors should be thoroughly familiar with the investigational product(s), the protocol, written informed consent form and any other written information to be provided to subjects, the sponsor’s SOPs, GCP, and the applicable regulatory requirement(s). Bhupal Noble University,Udaipur
  • 21. Monitoring in Clinical Trial contd. Monitoring Report  The monitor should submit a written report to the sponsor after each trial-site visit or trial-related communication.  Reports should include the date, site, name of the monitor, and name of the investigator or other individual(s) contacted.  Reports should include a summary of what the monitor reviewed and the monitor's statements concerning the significant findings/facts, deviations and deficiencies, conclusions, actions taken or to be taken and/or actions recommended to secure compliance.  The review and follow-up of the monitoring report with the sponsor should be documented by the sponsor’s designated representative. Bhupal Noble University,Udaipur