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Research Reference Guide A Comprehensive Handbook of Clinical Research Compiled by Health RAB & Medical Department PharmEvo Pvt. Ltd. [email protected] www.HealthRAB.org 402,Business Avenue,Block-6,P.E.CH.S Shahrah-e-Faisal ,Karachi-75400,Pakistan. 2 Message from the Chairman Dr. Abdul Gaffar Billoo Chairman, Health Research Advisory Board Aga Khan University Hospital, Karachi Professor, Department of Paediatrics and child Health I feel honored to chair the Health Research Advisory Board, a unique & visionary program, which is developed to promote & establish clinical research in Pakistan. Clinical research has always been very close to my heart simply because it allows us to help our patients effectively through evidence based knowledge and information. The importance of conducting indigenous clinical research cannot be over emphasized. Depending only upon research from western world does not allow us to treat our local population having local illnesses with a local solution. One of the objectives of Health RAB is to educate our clinicians and build their capacity in the field of clinical research. For this very purpose, Health RAB compiled this Research Reference Guide to help our physicians, mainly the younger generation, in understanding and then conducting clinical research in Pakistan. This guide takes us through the subject of clinical research in a simple and categorical manner covering nearly all its various aspects in a concise way. I am very optimistic that this initiative will go a long way not only in serving our patients better, but in creating visionary healthcare leaders in healthcare in Pakistan InshaAllah. 3 Message from the Vice Chairman Prof. Dr. Abdul Basit Vice Chairman, Health Research Advisory Board Director & Professor of Medicine Baqai Institute of Diabetes & Endocrinology, Karachi I feel honored to write about the Research Reference Guide which is a humble effort by Health RAB to assist our clinicians remain abreast with the various academic as well as procedural aspects of clinical trials and research in Pakistan. As a clinician who has been committed to clinical research throughout my career, I realize the significance of local research and its impact on clinical practice and health outcomes. This RRG is a comprehensive booklet which is developed keeping in mind the needs of all those who wish to be involved in clinical research. It is a one stop resource which includes an overview of some concepts & terminologies, a helpful check list, relevant SoPs & guidelines, a useful glossary and fundamentals of research, epidemiology, statistics & trials. I am confident that this RRG will contribute immensely in promoting research culture which in turn gives rise to research projects & activities in Pakistan InshaAllah. I hope and pray that this effort of ours helps you in your journey of clinical research and that our patients receive the real benefit of this endeavor InshaAllah. 4 Message from the General Secretary Dr. Zakiuddin Ahmed General Secretary, Health Research Advisory Board Medical Director PharmEvo (Pvt.) Ltd. As the general secretary of RAB, I feel privileged to present to you the Research Reference Guide, a handbook which comprises of valuable reference material required by clinicians, researchers and students alike. We realized that there wasn’t any single resource available for our Doctors which could provide most, if not all, the information about clinical trials, registration process, IRBs, proposal writing, etc. Therefore, in order to facilitate our Doctors in their need for finding relevant information from a single reference point, the leadership at Health RAB decided to compile a quick reference booklet. Health RAB, as you all know, is established by PharmEvo through a research grant, to promote clinical research in Pakistan through various value added activities and projects for the medical community at large. The RRG is yet another step towards building the clinical research ecosystem of our country and supporting those who are involved in clinical research in some capacity. I am hopeful that this resource will provide you most of the information which you seek in undertaking your research projects. I would like to thank the Health RAB leadership which provided the necessary guidance as well as the team at PharmEvo which helped develop this reference guide. 5 About Health Research Advisory Board (RAB) Health Research Advisory Board (RAB) is a “think tank” of senior clinicians, researchers & academicians who are committed to the mission of Health RAB which is to “Develop the Research Ecosystem of Pakistan”. The members of Health RAB represent major clinical specialties, medical institutions and associations and possess relevant expertise and experience to spearhead such a significant component of our health system. Objectives of Health RAB Provide leadership for developing the medical research ecosystem of Pakistan. Create synergy among the existing stake holders and bring them together. Build capacity of the human resource involved in conducting research. Collaborate & network locally as well as globally to initiate research activities in the country. Facilitate the development of a national research policy & strategy. 6 Advisory Council 1 Dr. Abdul Gaffar Billoo Professor, Department of Paediatrics and Child Health Aga Khan University Hospital, Karachi 2 Dr. Abdul Basit Professor of Medicine & Director Baqai Institute of Diabetes & Endocrinology, Karachi 3 Dr. Zakiuddin Ahmed Medical Director PharmEvo (Pvt.) Ltd. 4 Dr. Ejaz Ahmed Vohra Dean, Postgraduate Clinical Studies Chairman & Professor, Department of Medicine Ziauddin Medical University & Hospital, Karachi 5 Dr. Syed Shahid Noor Head, Department of Orthopaedic Surgery Liaquat National Hospital, Karachi 6 Dr. Kamran Hameed Consultant Rheumatologist & Dean Ziauddin Medical University & Hospital, Karachi 7 Dr. Tahir Shamsi Consultant Haematologist & Transplant Physician Medical Director National Institute Of Blood Disease & Bone Marrow Transplantation, Karachi 8 Dr. Bashir Hanif Consultant Cardiologist Medical Director TABBA Heart Institute, Karachi 9 Dr. Rufina Soomro Consultant Surgeon Liaquat National Hospital, Karachi 10 Dr. Naila Zahid Consultant Oncologist Liaquat National Hospital, Karachi 11 Dr. Shabeen Naz Masood Consultant Gynaecologist & Obstetrician Aga Khan University Hospital, Karachi 12 Dr. Tashfeen Ahmed Orthopaedic Surgeon & Researcher Aga Khan University Hospital, Karachi 13 Dr. Mohammad Saeed Consultant Rheumatologist & Head of Medical Research Liaquat National Hospital & Medical College, Karachi 7 Table of Contents Chapter 1 – Research and Research Methodology………………………………………………………………………………….13 Chapter 2 – Epidemiology Basics…………………………………………………………………………………………….................19 Chapter 3 – Clinical Trial Step by Step Overview……………………………………………………………….…………………..30 Chapter 4 – Types of Clinical Trials (Phase I – IV)…………………………………………………………………………………...52 Chapter 5 – International Conference on Harmonization – Good Clinical Practice (E6-R1)…………………….62 INTRODUCTION............................................................................................................................................64 1 GLOSSARY ...................................................................................................................................................65 2 THE PRINCIPLES OF ICH GCP........................................................................................................................72 3 INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)........................................72 3.1 Responsibilities............................................................................................................................................72 3.2 Composition, Functions and Operations .....................................................................................................74 3.3 Procedures ..................................................................................................................................................74 3.4 Records .......................................................................................................................................................75 4 INVESTIGATOR ............................................................................................................................................75 4.1 Investigator's Qualifications and Agreements.............................................................................................75 4.2 Adequate Resources ...................................................................................................................................76 4.3 Medical Care of Trial Subjects.....................................................................................................................76 4.4 Communication with IRB/IEC......................................................................................................................76 4.5 Compliance with Protocol ...........................................................................................................................77 4.6 Investigational Product(s)............................................................................................................................77 4.7 Randomization Procedures and Unblinding ...............................................................................................78 4.8 Informed Consent of Trial Subjects.............................................................................................................78

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