4.Clinical Trail Protocal and IRB or IEC.pptx

Clinical Trial Protocals, Composition of Institutional Ethical Committie, IRB, their functins

1. CLIN I CAL TRI A L PRTOCAL & IRB/IEC 1 Mr.B.Brahmaiah Assistant Professor Department of Pharmaceutical Regulatory Affairs & Pharmaceutics Shri Vishnu College of Pharmacy, Bhimavaram

2. Co n t e nt 2 Introduction T r i a l P r o tocol In s t it u t iona l R e vi e w B o a r d/ Independent Ethics Committee (IRB/IEC) Co m p o s iti o n of I R B /IEC Members of IRB/IEC R e s pon s ibi l itie s of I R B /IEC P r ocedu r es of IR B /IEC Maintenance of r eco r ds of I R B /IEC Reference

3. Introduction 3 What is a Clinical trial? prospective ethically designed investigation in It human s ubjects t o di s c o v e r / v e r ify/compa r e t he r e s ult s of t w o or m o r e ther a peutic measu r es (dr u gs) A clinicaI trial is a planned experiment that involves volunteers/patients Ai m t o co m par e t he r e s p o n s e to n e w t r ea t ment with that of an exis t in g one Clinical trial is just a part of New Drug Discovery Process.

4. Why are clinical trials important? 4 Clinical trials translate results of basic scientific research into better ways to prevent, diagnose, or treat disease The more people take part, the faster we can: A n s w er c ri t i c a l r es ea r c h q ues t io n s Fi n d b e t t er t r eatm e n t s a n d w a y s t o p r e v e n t d ise a se

5. Trial Protocol : 5 It is a complete written description and scientific rationale f or a r e s ea r ch a c t iv i t y i n v olving human s ubject s . TITLE PAGE SIGNATURE PAGE CONTENT PAGE L IS T O F A B B R E V I A T I O N S INTRODUCTION/ABSTRACT OBJECTIVES BACKGROUND/RATIONALE ELIGIBILITY CRITERIA STUDY DESIGN/METHODS (INCLUDING DRUG/DEVICE INFO) SAFETY/ADVERSE EVENTS REGULATORY GUIDANCE S T A T IS T I C AL S E C T I O N ( I N CLU D I N G AN A L Y S IS AN D MONITORING) HUMAN SUBJECTS PROTECTIONIINFOR1\1ED CONSENT

6. TITLE PAGE : 6 Title page introduce the document ,its title, precise numbe r , s pon s or and author to the r e a de r . Protocol identifying number and date. The protocol number must clearly indicate the version numbe r , whe t her i t i s fin a l or d r aft and date of t his version.

7. Title page should includes: Full title should include summary study design, medicinal products ,nature of treatment (eg : treatment and diagnosis) indication patient population setting (eg : in-patient, outpatient) Randomised d o ub l e b ind m u l t i p l e stud i es. Name and address of sponsor and monitor. Sponsor names and list of responsibilities with agreed allocations Name and address of the authorised person to sign the protocol and protocol amendment for the sponsor. Generally, chief investigator for trial or principle investigator for single center trials. Name ,title, address and telephone number of the sponsor medical exp e r t f o r t he t ria l Name and title of the investigator who is responsible for conducting the trial, and the address and telephone number of the t ria l si t e . Name, title, address and telephone number of the qualified physician who is responsible for all trial site related medical decisions. Name and address of the clinical laboratory and other medical or technical or institutions involved in the trial. 7

8. SIGNATURE PAGE : 8 Signature page of all healthcare professionals in the trial in c ludin g contact detai l s of p a r ticip a ting s it e , s pon s or and sponsor medical advisor if not already given above. CONTENT PAGE : This help navigation through the document by large n umber of dif f e r ent people that wil l be neede d th r oughout the tri a l.

9. LIS T O F ABBREV I A T I ONS : 9 All abbreviations used should be listed and defined. A c c epted inte r na ti o na l medic al abb r e vi ations s hould be s tanda r di s ed withi n e a c h p r oject. INTRODUCTION / ABSTRACT : This summary should be only one to two pages long. It should give the reader sufficient information to unde r s tand the r ationa l e f or the t r i a l , it s obje c ti v e and the me t h o ds t hat wil l be u s ed to a c hi e v e t he s e objecti v e .

10. OBJECTIVES : 10 Objectives should be stated clearly as hypotheses to be tested. Each objective should have a corresponding discussion i n the s tati stical s ec ti o n. B A CKG R O U N D A ND RATIONALE : All p r o t o co l s r equ i r e a s ect i o n deta i l i ng the s c i ent i fic rat i o nale f o r a p r o t o c o l and the j u s t i f i c a t i o n i n medical and s cien t i f i c l i te r atu r e f o r the h y poth e s i s be i ng p r o po s ed. Int r o duc t o r y s ect i o n s h o u l d be o rgan i zed i n a l o gic a l , s equ e ntial fl o w .

11. ELIGIBILITY CRITERIA - DEFINITION : 11 Inclusion and exclusion criteria are the conditions that m u s t be met i n o r der to p a r ticip a te i n a cl ini c al tri a I . The most important criteria used to determine appropriateness for clinical trial participation include a g e , s ex, the t ype and s t a g e of a di s ea s e , t r ea t ment history, and other medical conditions.

12. STUDY DESIGN : 12 T he de s i g n s t udy s ec t io n of t he p r o t ocol s hould c on t a i n a stepwise description of all procedures that required to by study. A g o o d s t udy de s i g n s ec t io n in c lud e s s uffi c i e nt in f o r m a t ion f or t he pa r t i c ip a tin g s it e . Parts of the study design section may include: In i t i al e v a l uati o ns Sc r e e n i ng te s ts Requ i r ed l ab te s ts Detai l s o f t r eatment or p r o c edu r es Device specifications Do s e s chedul i ng and m o dif i c ati o n Calendars

13. SAFTEY : 13 Adverse effect and side effect are terms commonly associated with drugs.They are used by nurses and doctors, to refer to undesirable effects of a medication on a pa tien t . The Safety (or Adverse Events) section should include: Detailed information for reporting adverse events, including reporting to the FDA and/or the sponsor Unb l indin g p r oce s s es ( i f a ppl i c a ble) L i s t s of exp e ct ed a d v e r s e e v ents

14. THE STATISTICAL SECTION: The study objectives and study design elements in the statistical section should be described in the Objectives section T he de s c r iption s a nd d e finitions of t o xic itie s i n the statistical section match those in the Safety/AE section. HUMAN SUBJECTS PROTECTION : • T his s ec ti o n i ncl udes d i s cus s io n of: S u b je c t sele c t io n a n d e x c l u sion P r o p ose d me t h ods of p a t ie n t r ecru itme n t Minority representation Recruitment (or exclusion) of special subjects, including v ul n er a b l e s u b je c t s Lists of potential risks and benefits, including justification for risks. 14

15. Institutional Review Board / Independent Ethics Committee (IRB/IEC) : 15 IRB/IEG serves as an independent body that reviews, evaluates, approves and decides on the scientific and ethical aspects of the clinical trial protocol as well as the benefits and risks to the study participants Ma i n pu r po s e of I R B /IEG i s to p r o t ec t t he r i g h t s , s a f et y , and well-being of the subjects who participate in a trial

16. Composition of IRB/IEC : 16 Con s i s ts of membe r s , w ho colle c ti v e l y h a v e the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the trials. Includes at least five members, of which at least one me m ber whos e p r ima r y a r ea of in t e r e s t i s n o n - scientific, and at least one member who is independent of t he ins t it u t ion / t r i a l si t e .

17. MEMBERS OF IEC 🠶 Chair person 🠶 1-2 basic medical scientists 🠶 1-2 clinicians from various institutes 🠶 One legal expert or retired judge 🠶 One social scientist 🠶 One philosopher/ethicist 🠶 One lay person 🠶 Member Secretary

18. Responsibilities of IRB/IEC : 18 Safeguard the rights, safety, and well-being of all trial subjects. Reviews a proposed clinical trial within a reasonable ti m e and document i ts v i e w s i n w r iting. Conducts con t i n uing r e vi e w of ea c h o n g oing t r i a l at le a s t o nce per y e a r . Ensures that information regarding payment to subjects ( in c ludin g the me t hod s , a m o unts , s che dule of p a yment) i s s et f o r t h i n t he w r it t en inf ormed con s ent f orm and any other written information is provided to the subjects.

19. Procedures of IRB/IEC : 19 Deter mines it s c o m po s itio n and author i ty under whi c h i t i s e s tabli s hed. Sc hedule s , no t ifi e s it s membe r s of, and conducts i ts meetings. Conducts initia l and con t i n uing r e vi e w of t r i a l s . Spe ci fies that no s ubje c t s hould be adm i t t ed to a tri a l before the IRB/IEC issues its written approval or f a v ora ble opinion of the tri a l. Specifies the information that the investigator should report to the IRB/IEC (like deviations from the p r o t ocol, a d v e r s e d r ug r e a ctions etc ).

20. Maintenance of records of IRB/IEC : 20 I R B /IEG r etains a l l r el e v a nt r ec o r ds (e . g . , w r it t en procedures, lists of occupations/affiliations of members, submitted documents, minutes of meetings, etc.) for a pe r io d of a t le a s t 3 y e a r s after complet of the t r i a l and ma k es them a v a il a ble upon r equest f r om the r e g ul a t o r y authority(ies) I R B /IEG m a y be as k ed b y i n v e s tig a t o r s , s pon s ors, or regulatory authorities to provide copies of its written p r ocedu res a nd me m be r s hip l i s t s .

21. Re f e r e n ces : 21 https://www.slideshare.net/mobile/ssuserfe3019/clinical- trial-protocol-development Assessed Date: 25/02/2021 https://www.slideshare.net/mobile/TSDP/institutional- review-boardindependent-ethics-committee-irbiec A s s e s s ed Date: 25/0 2 /2021 https://www.slideshare.net/mobile/ChintanDoshi17/clini c a l - t r i a l - 12009020 6 A s s e s s ed Date: 25/0 2 /2021 https://www.slideshare.net/mobile/uttara2024/clinical- trials-types-and-design Assessed Date: 25/02/2021

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