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NIZAM’S INSTITUTE OF MEDICAL SCIENCES
(A UNIVERSITY ESTABLISHED UNDER THE STATE ACT) PUNJAGUTTA, HYDERABAD- 500 082 (A.P.)
REGULATIONS FOR ADMISSION INTO PG DIPLOMA IN CLINICAL RESEARCH COURSE IN NIMS, HYDERABAD, ANDHRA PRADESH I. (1) These regulations may be called the Nizam’s Institute of Medical Sciences Regulations of Admission Rules 1996. They shall apply to the P.G.Diploma in Clinical Research Course offered at the Institute.
NUMBER OF SEATS, DURATION OF COURSE AND MINIMUM QUALIFICATION REQUIRED Seats Duration30 12 months Prior Qualification Candidates who have passed Bachelors degree in Medicine, Dentistry, Pharmacy, Life Sciences with a minimum of 50% aggregate marks in the qualifying examination. .
Subject Post Graduate diploma in Clinical Research (PGDCR)
III. APPLICATIONS A candidate must create an application on the web available on http://www.nimsexams.net/ and hardcopy of web generated application must be submitted along with draft / NIMS cash receipt along with other necessary supporting documents. Hardcopy must have affixed passport sized black / white photograph, thumb impression and signature of the candidate.
4. the total marks obtained in Oral Aptitude Test (Interview) shall be taken into consideration for fixing merit of the candidates. SCREENING CANDIDATES FOR INTERVIEW Percentage of marks in qualifying graduate examination. Punjagutta. 2. the older candidate being given priority. 5. in case of further tie. Application fee is non-refundable even if the application is summarily rejected.000/. NIMS Punjagutta. No individual letters shall be sent to the candidates for interview. Hyderabad – 500 082. The candidates will be called for the interview in 1:3 ratio. ii) In case of equality of marks in graduate examination. Web generated hardcopy with all necessary documents shall be submitted in person or sent by Post to the Sub-Dean. The filled in applications received after the prescribed date and time shall not be considered. Hyderabad 500 082. Examination Cell. 6.1. See Part I of regulations for detailed instructions and procedure. Examination Cell. The candidates must write his/her name and application number on the back side of the Bank Draft/NIMS Cash Receipt. The Institute will not be responsible for non-receipt of applications or delay in postal transit IV 1. Andhra Pradesh on or before the prescribed date as described in part I of regulations. Enclose Demand Draft of Rs1. 3. i) The selection shall be based on the merit on the percentage of marks in graduate exam and oral aptitude test. age shall be taken into consideration.(Rupees One thousand only) drawn in favour of the Director. .2 Only web generated applications will be accepted and processed. No request for postponing the date of interview or request to appear at an earlier date shall be entertained. In the event a candidate fails to report for the interview at the date and time specified the seat shall be offered to the next merit candidate as per the waiting list. Nizam’s Institute of Medical sciences or by paying Rs. In case of any seat falling vacant within one month of starting of the course.in the NIMS Cash Counter in person and submit along with application in SubDean.000/. A candidate can create only one web application. Number of attempts for passing graduate qualifying examination Experience in Clinical Research Preference will be given to the students with Postgraduate qualification. shall be filled by the next candidate in waiting list only. Nizam’s Institute of Medical Sciences.
the decision of the Institute shall be final and binding on the candidates and selection cannot be questioned after admissions are closed. All those candidates who are selected for admission have to pay the fee as specified at rule XIII (2) and submit the original certificates on the date and time specified in Part 1 of the regulations.10-07-1979 & Rule of reservation. participants should be able to: (i) Distinguish the variety of clinical research/trials . 10. Failure to submit the above certificates shall render the candidate being ineligible. 8. The date of the admission is detailed in Part 1 of the regulations. They shall have to come for admission on the date notified.P.646. In all matters relating to selections and admission. Failure to submit the required certificates or pay the fee shall render the candidate in forfeiting the seat and such seat shall be allotted to the next merit candidate as per admission regulations. They shall also produce a certificate from the institution that they have no objection to the candidate’s admission to the PG Diploma in Clinical Research and in the event of selection of the candidate to the course he/she shall be relieved immediately. 11. To build manpower capacity for clinical research/trial. 9. Candidate appearing for the Interview test will not be paid any traveling allowance. Non-attendance to the admission shall render the candidate forfeiting his/her admission. For in-service candidates who are pursuing studies and who cannot deposit the original certificates at the time of admission have to bring Xerox copies of the original certificates duly attested by the controlling authorities of the Institution. The selection shall be based on the merit ( Percentage of marks+Marks in the oral aptitude (Interview) and as per the G.3 7. V MAIN OBJECTIVES To impart knowledge and experience and understanding of the basic principles of scientific method as applied to clinical research. dt. Candidates have to report for admission in person with required documents as detailed in AnnexureI. VI EDUCATIONAL OBJECTIVE: Upon completion of this course.O. To provide skills in using the necessary methodology and statistical tools and technique for designing and conducting clinical research.
(viii) Become familiar with the IEC/IRB application process.4 (ii) Relate clinical trial as it applies in the new drug development process (iii) Evaluate the key elements of clinical research design to assure study validity and rigor (iv) Understand statistical issues involved in the protocol and data analysis (v) Discuss key ethical issues arising in research involving human subjects (vi) Outline key Indian DCGI/ICMR and international regulatory requirements governing clinical research/trial (vii) Value the roles of the variety of professionals involved in trial conduct . VII. . VIII.00 PM to 6. COURSE REQUIREMENT AND EVALUATION The training course will be class room teaching lectures. with group discussions. guidelines and Good Clinical Practices. write documents and Prepare reports. apply monitoring methods. The curriculum provides comprehensive training across the entire clinical trials process. statistics and writing for clinical research. including courses from the perspective of the clinical study site as well as that of the sponsor or monitor and covers good practices. tutorials and hands-on exercises. BENEFITS TO PARTICIPANTS: (i) Learn to plan and manage a site as a coordinator (ii) Develop and manage comprehensive clinical research/trials budgets (iii) Learn to Analyze the initial review of a new protocol (iv) Understand why and how to implement a monitoring visit (v) Learn and apply basic concepts to protocol development (vi) Initiate clinical research. The classes will be held once in a week (every Friday between 4. regulatory requirements and compliance. (viii) Critically evaluate clinical research/trial protocol (ix) Critically appraise results of published research/trial report. while understanding and abiding by regulations.00 PM). (vii) Describe all elements of a new drug application. focusing on clinical areas.
ABOUT THE COURSE This course uses the Principles of International Conference on Harmonization (ICH) GCP Guidelines. The decision of the Medical Board shall be final. The Medical Board appointed by the Institute will decide the medical fitness.50.book recording their week-to-week academic activities. 6. . . 5 The Institute shall fix duties and responsibilities of students from time to time. A minimum of 75% attendance for classroom teaching is required for appearing in the final theory examination.000/- 3. X. The selection of each student will be subject to medical fitness. . All selected candidates must maintain a log .cost of teaching material. 2. 4.. The course runs over a period of 12 months.. which are to be submitted to the Dean through Proper Channel once in 2 months 7. The course is part time and will be once in a week (every Friday between 4. students who secure minimum 50% marks will be declared successful. ADMISSION REGULATIONS 1 The original certificates submitted by the candidates shall not be returned to the candidates till they complete their course of study and appear for the final examination. FINAL EXAMINATION At the end of 12 months of classroom teaching.00 PM to 6..library fee and examination fee Rs. Fee structure Annual fee Tuition fee. the final theory + viva examination will be conducted. The tuition fee once paid is not refundable under any circumstances.00 PM).5 IX. DIPLOMA CERTIFICATE WILL BE AWARDED ONLY TO THOSE CANDIDATES WHO PASSED THE FINAL THEORY + VIVA EXAMINATION. XI..
1. The duration of the course shall be calculated from the date of commencement of the course without any reference to the date of joining of any individual. insubordination. misconduct or any other offences amounting to moral turpitude on the part of the candidate which in the opinion of the Head of the Institute makes it undesirable to continue the candidate in the Institute. All students shall adhere to the Institutional rules and violation of rules will be viewed seriously. The admissions shall stand closed within one month from the date of commencement of the course. such candidate has furnished incorrect particulars/or false information . Violation of the conduct rules will result in the cancellation of the admission of the candidates apart from invoking the terms and conditions of the bond. 10. XIV. the Dean of the Faculty of the Institute may at any time before completion of the course either on his/her own motion or on the application of any person after due and proper enquiry and after giving the person 2 weeks time from the date of receipt of the show cause notice to submit the written explanation and on personal hearing order the cancellation of admission to the course. DISCONTINUATION OF THE COURSE Candidates are permitted to discontinue the course under the following conditions without any penalty. 9. POWERS OF DEAN Notwithstanding anything contained in these regulations. The students shall maintain strict discipline during the period of study/training programme in terms of conduct rules of the NIMS. If a canididate is absent for more than 30 days without approval he/she shall be treated as deemed to have discontinued and fee shall not be refunded. TERMINATION OF TRAINING AND DISMISSAL A candidate admitted to the course shall be liable for dismissal at any time before the completion of the course on account of negligence. Resultant vacancies shall be filled by the candidates belonging to the same category as those who vacated the corresponding seat. . XV.. CLOSURE OF ADMISSIONS 1. XIII. Illness certified by the Medical Board of the Institute 2. if in his/her opinion.6 8. failure to attempt to the prescribed studies and duties. XII. The candidate shall not resort to any strikes during the period of their study in dereliction of their duties or air their views criticizing the policies of the Institute either before the print or electronic media or anywhere.
7 in the application or in the document attached thereto or in the statements made either before the authority in charge of admissions or the Dean or any other manner. the concerned student shall be given liberty to explain and if his/her explanation is not found satisfactory. dated 21-08-1997. If any incident of ragging comes to the notice of the authority. Hyderabad.Act. NIMS. DIRECTOR NIMS ANTI RAGGING ACT: Ragging is prohibited in the Educational Institutions in the State of Andhra Pradesh. the appeal shall be with the Director. Punjagutta.No. vide.26 of 1997. …… . Against any such order of the Dean. the authority would expel him/her from the Institution.
________________ in favour of Executive Registrar..8 ANNEXURE-I FORM OF BOND TO BE EXECUTED BY A CANDIDATE JOINING PGDCR COURSE. WITH SURITY (On Non Judicial Stamped paper Rs. The Sureties are signed this bond in the presence of the following witness on this day____ of______2010 Witness:1 Surities: 1 2. This Bond is executed in the presence of the following witness. In case of cancellation/discontinuance of the said course by the student will be liable to pay the said bond amount and the amounts if any received from the NIMS by way of stipend etc. We undertake the liability of the above bond amount to an extent of bond amount as well as the stipend if any received by the student/executor of the Bond.000/(Rupees ten thousand only) in favour of the Executive Registrar. If the student/executor of the said bond fails to discharge his/her obligations under the said bond. Hyderabad. The bond will come into force from date of selection. the gazetted officers/faculty 1)_________________ S/o____________________ R/o__________________________ working as______________ 2)_________________ S/o____________________ R/o_________________________ working as_______________ We hereby stand as sureties to the Bond executed by Mr/Ms. Punjagutta. NIMS. (NIMS).____________ S/o/Do _____________ R/o___________________________________________ hereafter called as “STUDENT”in favour of the Executive Registrar. we will pay the said amount as and when the NIMS demand. WHEREAS the said student selected for the course of Post Graduate Diploma in Clinical Research in the NIMS for the Academic year 2010 WHEREAS the NIMS Institute has prescribed/stipulated the condition in admission regulations that the student selected for course have to execute bond for Rs. ____________________ Witness:1) signature of the student Full name with address 2) Full name with address We.100/-) This Bond is executed on this ___day of______2010 by Mr/Ms. NIMS promising that he/she will complete the course. Whereas the student selected has agreed to the said conditions and executing this bond. The signature of the surety should be supported by seal/rubber stamp.10. . Surities: 2 NB: Sureties should be not below the rank of two permanent Gazetted Officers. Punjagutta. Nizam’s Institute of Medical Sciences. Hyderabad hereafter called as the” NIMS Institute”.
as the case may be. Where. Such local area where he/she has resided for the maximum period out of the said period of seven years. OR ii. but has resided in the state during the whole of the said period of seven years.9 Annexure – II DEFINITION OF LOCAL / NON-LOCAL STATUS 1.1. 1. Where the period of his/her study in two or more local areas is equal. OR ii. A candidate who is not regarded as local candidate under clause (1. If he/she studied in the educational institutions in the state for a period of not less than seven academic years ending with the academic year in which he/she appeared or first appeared for the relevant qualifying examination as the case may be. if he/she resided in that local area for a period of not less than four years immediately preceding the date of commencement of the relevant qualifying examination in which he/she appeared. . during the whole or any part of the four consecutive academic years in which he/she appeared. in any local area.1) above in relation to any local are shall 2. be regarded as a local candidate in relation to. Such local area where he/she studied for the maximum period out of period of seven years.1. i. or first appeared in the relevant qualifying examination. A Candidate shall be regarded as a local candidate in relation to a local area (AU/OU/SVU) If he/she has studied in an Educational Institution or Educational Institutions in such local area for a period of not less than four consecutive academic years ending with the academic year in which he/she appeared or first appeared in the relevant qualifying examination as the case may be. or first appeared.2. such local area where he/she studied last in such equal periods.2. he/she has not studied in the educational institutions. he/she has not studied in any educational institutions. 2. 1. If during the whole or any part of the seven consecutive academic years ending with the academic year in which he/she appeared or first appeared for the relevant qualifying examination.. be regarded as a local candidate in relation to. i. Where the period of his/her residence in two or more local areas is equal such local area where he/she had resided last in such periods.
Candidates either of whose parents is employed in the State of A.07. Candidates who are spouses of those employed in the State of A. Local Bodies. Local Bodies. 646. OR c. in respect of Osmania University (OU area). 3. it includes Sri Krishnadevaraya University area.1979 Note: Any period of study in State-wide University or a State-wide educational Institution/State-wide course as defined in the schedule to the Presidential Order. the . at the time of submitting the application. Candidates either of whose parents has resided in this state for a total period of 10 years or more excluding the periods of employment outside the state. dated 10. Candidates who have resided in the state of AP for a total period of 10 years or more excluding the period of study outside this state. Candidates coming under any of the categories given below and not satisfying conditions mentioned in 1 or 2 above are treated as Non-Local to all the three Univesity areas specified above. a. Public Sector Corporations.P in the State or Central Government Public Sector Corporations. No. OR b. 1974 shall be disregarded for determining the University area. Universities and other similar quasi Government Institutions within this state.P in the State or Central Government. at the time of submitting the application.O. it includes Kakatiya University area. OR d. Universities and other similar quasi Government Institutions within this state.U area) includes Nagarjuna University area In respect of Sri Venkateswara University (SVU area).10 Note: Local area in respect of Andhra Pradesh (A. For full details refer G.
The Medical Board constituted by the NIMS will scrutinize/verify the Disability candidates and candidates claiming reservation under PH for Confirmation of eligibility.109 Women’s development Child Welfare and Labour Department dated 15-06-1992. The certificate should be taken within 3 months prior to the last date of presenting his/her application for seeking admission in any course by claiming the benefit of reservation. 7. 1979. Order 1974: i) Bonafide study certificate for 7 years (9th to Degree) from the Head of the Institutions OR ii) Residence certificate of candidate for a total period of 10 years in A. . Transfer/Migration certificate of degree 8.. 9. excluding the period of study outside the State of Andhra Pradesh issued by MRO/Tahsildar OR iii) Residence Certificate of parents for a total period of 10 years in A. SC and ST candidate (if applicable) . AP Educational Institutions (Regulation of Admissions). 5. Social Status certificate in the prescribed format in the case of BC.P.P. excluding periods of employment outside the State of Andhra Pradesh from MRO/Tahsildar The residence certificate of candidate from MRO/Tahsildar. 1979. Differently abled (PH) certificate where applicable. by the Medical Board vide G. dated 10th July. Documents in support of local candidature as defined in the Presidential Order (GOP 646. Marks Memo of degree 3. Provisional/Final certificate of Degree 4.11 ANNEXURE III List of Original Certificates to be submitted at the time of Admission: 1.Ms.No. Study& Conduct Certificate of degree course issued by the Principal of the college where last studied. 6. must be in the format described in the GOP 646 dated 10th July.O. where applicable. Marks Memo of 10th class/Proof of date of birth 2. Relieving order from the employer (in case of in-service candidates).
library fee and examination fee Rs. Fee to be paid: Annual fee Tuition fee.000/- 11.50.Bond as per annexure I -oOo- .12 10.cost of teaching material.
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