Short Courses on Biostatistics

The Department of Biostatistics at Christian Medical College

About Organization:

Christian Medical College is in internationally reputed medicalcollege and tertiary care hospital which was started in 1900 by Dr.lda Sophia Scudder, a young American missionary. Through its continued dedication to health care, education and research,CMC has earned a reputation as one of the leading institution in India. Today CMC offers 90 recognized training programs in medical, nursing and paramedical fields. It is 2234 bed multispecialty,tertiary care teaching hospital, which comprises of a vital, diverse and Inter-denominational community.

They are conducting Short courses on Biostatistics. For the details of forthcoming Events please see the below or you can visit their website:

Forthcoming Events:

Short courses

November

Instrument Development” and Qualitative Research Methods and Analysis
Nov 23-28, 2009
IndiaCLEN in collaboration with Samarth is commencing its workshops on social science on ""Instrument Development” and Qualitative Research Methods and Analysis" scheduled to be held from, 23rd - 28th November 2009 at the Biostatistics Resource and Training Centre (BRTC), Department of Biostatistics, Christian Medical College, Adjacent to College Chapel, Bagayam, Vellore 632 002. Those interested in participating can contact us through e-mail (admin@samarthngo.org) or call us at +91 44-45010070. Attached are the registration form and details regarding the workshops. To confirm your participation in the workshops, please send your fees with the registration form.
Download Application

December

Fundamentals of Biostatistics, Principles of Epidemiology & Statistical Package for Social Science (SPSS)
Nov 30-Dec 4, 2009
This course is intended to introduce principles of Biostatistics, in a simpler manner to researchers who are in need of statistical application. This course is also intended to introduce principles and illustrate some of the basic methods of epidemiologic research and to improve the participant’s ability to understand and use appropriate statistical procedures.
The course is targeted towards researchers of varied profession such as medicine, public health, life science, social science, nursing, epidemiology, biostatistics etc.
Venue: The course will be held at the Biostatistics Resource and Training Center (BRTC), Dept. of Biostatistics, Christian Medical College, Bagayam, Vellore 632 002.
Course Fee & Accommodation: Nominally fixed at Rs 3,500/- per course. If more than one course is opted then Rs. 3,000/- per course will be charged, however the course fee for “SAS” course is fixed at Rs. 5,000/-.
Participants will have to bear their own expenses for travel, boarding and lodging. The Organizers will give lunch and snacks. However the organizers may arrange accommodation on request.
Course Fee should be paid in full by November 20, 2009. Payment can be made by Demand Draft in favor of “Christian Medical College Vellore Association Account”, payable at Vellore.
Note: After Registration if cancelled the course fee will not be refunded
The number of participants for each course is limited to 30 and admission will be purely on first come first served basis.
Download Application

Multilevel Modeling (MLM) and Generalized Estimating Equations (GEE)
Dec 7-11, 2009
This course is intended to introduce the concept of multilevel theories and statistical treatment of clustered data. This course enables the statisticians to understand the concepts of Multilevel Modeling (MLM), Generalized Estimating Equations (GEE) and their applications. This course also provides real time examples that will be analyzed using SAS software.
Venue: The course will be held at the Biostatistics Resource and Training Center (BRTC), Dept. of Biostatistics, Christian Medical College, Bagayam, Vellore 632 002.
Course Fee & Accommodation: Nominally fixed at Rs 3,500/- per course. If more than one course is opted then Rs. 3,000/- per course will be charged, however the course fee for “SAS” course is fixed at Rs. 5,000/-.
Participants will have to bear their own expenses for travel, boarding and lodging. The Organizers will give lunch and snacks. However the organizers may arrange accommodation on request.
Course Fee should be paid in full by November 20, 2009. Payment can be made by Demand Draft in favor of “Christian Medical College Vellore Association Account”, payable at Vellore.
Note: After Registration if cancelled the course fee will not be refunded
The number of participants for each course is limited to 30 and admission will be purely on first come first served basis.
Download Application

SAS (Statistical Analysis System) Software Training
Dec 14-18, 2009
This course is intended to introduce the basic concepts to use SAS, in a simpler manner to researchers who are in need. This course is also planned to furnish the basic and some advanced statistical analyses techniques with real time datasets so as to improve the participant’s ability to understand and interpret the findings.
The course is targeted towards researchers of varied profession such as medicine, public health, life science, social science, nursing, epidemiology, biostatistics etc.
Note:The participants should have basic knowledge in computers.
Venue: The course will be held at the Biostatistics Resource and Training Center (BRTC), Dept. of Biostatistics, Christian Medical College, Bagayam, Vellore 632 002.
Course Fee & Accommodation: Nominally fixed at Rs 3,500/- per course. If more than one course is opted then Rs. 3,000/- per course will be charged, however the course fee for “SAS” course is fixed at Rs. 5,000/-.
Participants will have to bear their own expenses for travel, boarding and lodging. The Organizers will give lunch and snacks. However the organizers may arrange accommodation on request.
Course Fee should be paid in full by November 20, 2009. Payment can be made by Demand Draft in favor of “Christian Medical College Vellore Association Account”, payable at Vellore.
Note: After Registration if cancelled the course fee will not be refunded
The number of participants for each course is limited to 30 and admission will be purely on first come first served basis.

Download Application

May/June

Fundamentals of Biostatistics, Principles of Epidemiology & Statistical Package for Social Science (SPSS)
May 24-28, 2010
This course is intended to introduce principles of Biostatistics, in a simpler manner to researchers who are in need of statistical application. This course is also intended to introduce principles and illustrate some of the basic methods of epidemiologic research and to improve the participant’s ability to understand and use appropriate statistical procedures.
The course is targeted towards researchers of varied profession such as medicine, public health, life science, social science, nursing, epidemiology, biostatistics etc.
Venue: The course will be held at the Biostatistics Resource and Training Center (BRTC), Dept. of Biostatistics, Christian Medical College, Bagayam, Vellore 632 002.
Course Fee & Accommodation: Nominally fixed at Rs 3,500/- per course. If more than one course is opted then Rs. 3,000/- per course will be charged, however the course fee for “SAS” course is fixed at Rs. 5,000/-.
Participants will have to bear their own expenses for travel, boarding and lodging. The Organizers will give lunch and snacks. However the organizers may arrange accommodation on request.
Course Fee should be paid in full by May 14, 2010. Payment can be made by Demand Draft in favor of “Christian Medical College Vellore Association Account”, payable at Vellore.
Note: After Registration if cancelled the course fee will not be refunded
The number of participants for each course is limited to 30 and admission will be purely on first come first served basis.

Clinical Trial and Meta Analyses
May 30-June 4, 2010
The course intends to explain the design, analysis and interpretation of clinical trials and Meta Analyses. This course is targeted towards epidemiologists, biostatisticians, demographers and other researchers.
Venue: The course will be held at the Biostatistics Resource and Training Center (BRTC), Dept. of Biostatistics, Christian Medical College, Bagayam, Vellore 632 002.
Course Fee & Accommodation: Nominally fixed at Rs 3,500/- per course. If more than one course is opted then Rs. 3,000/- per course will be charged, however the course fee for “SAS” course is fixed at Rs. 5,000/-.
Participants will have to bear their own expenses for travel, boarding and lodging. The Organizers will give lunch and snacks. However the organizers may arrange accommodation on request.
Course Fee should be paid in full by May 14, 2010. Payment can be made by Demand Draft in favor of “Christian Medical College Vellore Association Account”, payable at Vellore.
Note: After Registration if cancelled the course fee will not be refunded
The number of participants for each course is limited to 30 and admission will be purely on first come first served basis.

Multiple Linear Regression, Logistic Regression & Survival Analysis
June 7-11, 2010
This course is intended to improve participant’s ability to conduct regression analyses and study the relationship between response variable and multiple predictor variables. This course is also intended to sharpen the skills of analyzing binary outcome data and interpreting regression coefficients.
This course is targeted towards epidemiologist, biostatisticians, demographers and other medical researchers.
Venue: The course will be held at the Biostatistics Resource and Training Center (BRTC), Dept. of Biostatistics, Christian Medical College, Bagayam, Vellore 632 002.
Course Fee & Accommodation: Nominally fixed at Rs 3,500/- per course. If more than one course is opted then Rs. 3,000/- per course will be charged, however the course fee for “SAS” course is fixed at Rs. 5,000/-.
Participants will have to bear their own expenses for travel, boarding and lodging. The Organizers will give lunch and snacks. However the organizers may arrange accommodation on request.
Course Fee should be paid in full by May 14, 2010. Payment can be made by Demand Draft in favor of “Christian Medical College Vellore Association Account”, payable at Vellore.
Note: After Registration if cancelled the course fee will not be refunded
The number of participants for each course is limited to 30 and admission will be purely on first come first served basis.

SAS (Statistical Analysis System) Software Training
June 14-18, 2010

Source:
http://www.cmc-biostatistics.ac.in/news.html

FDA Releases Draft Guidance for REMS

Risk Evaluation and Mitigation Strategies (REMS)

The US Food and Drug Administration published its first draft guidance for industry about Risk Evaluation and Mitigation Strategies (REMS) on Sept. 30, 2009. The document describes the format and content of a proposed REMS, including supporting documentation, the content of assessments and proposed modifications of an approved REMS, which identifiers should be used on REMS documents, and how to communicate with FDA about a REMS. The guidance also provides an example of what an approved REMS might look like.

“With this new guidance, manufacturers will have a useful blueprint for how to develop these important safety strategies,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in a press release.

According to the draft guidance, a proposed REMS submission to FDA should include a proposed REMS, which concisely describes the proposed goals and elements of the REMS, and a REMS supporting document that provides additional information such as a thorough explanation of the rationale for, and supporting information about, the content of the proposed REMS. All proposed materials that are included in the REMS (e.g., proposed communication and education materials, Medication Guide, elements to assure safe use, patient package insert, enrollment forms, and prescriber and patient agreements) should be appended to the proposed REMS. A template for the proposed REMS is available on FDA’s website.

The REMS supporting document should thoroughly explain the rationale for and supporting information about the content of the proposed REMS, according to the draft guidance. The REMS supporting document should describe how and when each REMS element will be implemented and specify the rationale for the timelines and milestones. If any REMS activity will not be implemented at the time of REMS approval, the REMS supporting document should describe the reason for the implementation schedule. “For example, the document should address the rationale for whether a communication plan would be implemented before, or concurrently with, other elements,” the draft guidance says. A template for the REMS supporting document can also be found on FDA’s website.

In addition, the draft guidance describes REMS policies for certain regulatory situations. The draft lists FDA websites where documents about approved REMS will be posted. The FDA Amendments Act of 2007 granted FDA the authority to require the submission and implementation of a REMS if the agency determines that it is necessary to ensure that a drug’s benefits outweigh its risks. Future draft guidances will address additional REMS topics, according to an agency press release.

The following links are for the guidelines:

1.http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM184128.pdf
2.http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/default.htm

Source: Pharmtech.findpharma.com, USFDA Site

GUIDELINES FOR STANDARD OPERATING PROCEDURES

for Good Statistical Practice in Clinical Research

Written by: PSI Professional Standards Working Party


INTRODUCTION

Professional codes of conduct for statisticians, such as those published by the Royal Statistical Society, stress general principles including the need for professional integrity, a primary concern for the public interest and the preservation of professional standards. However, there is a need for more detailed guidance in specific disciplines. Therefore, the PSI “Professional Standards Working Party” set out to provide guidance for the preparation of Standard Operating Procedures (SOPs) for Good Statistical Practice in clinical research.

The development of Guidelines for Standard Operating Procedures (GSOPs) appeared to be a natural step in the process of encouraging and publicising Good Statistical Practice in the analysis and reporting of clinical trial data. In preparing these GSOPs, the objectives of PSI are:

• to ensure that statisticians in the pharmaceutical industry are aware of the principles contained in published codes of conduct
• to provide guidance to encourage adherence to these principles in the application of statistics to clinical trials
• to publicise the principles of Good Statistical Practice for clinical research to other professionals, internal and external to the pharmaceutical industry
• to provide guidance in the preparation of SOPs to ensure compliance with the requirements of international Good Clinical Practice so as to satisfy regulatory requirements with respect to the collection, processing, analysis and reporting of clinical trial data.

The many varied roles statisticians fulfil within the pharmaceutical industry and related organisations (e.g. academic institutions and Contract Research Organisations (CROs)) preclude writing a definitive set of SOPs for all PSI members. Hence the decision was taken to develop GSOPs which would give detailed statements of the principles of Good Statistical Practice within the context of clinical research (thus building on the existing codes of conduct), but which would require that statisticians develop the guidelines into SOPs specific to their own organisations. Conversion of these GSOPs into SOPs appropriate for a specific organisation requires expertise. Care should be taken that the level of responsibility given to statisticians is appropriate to the level and depth of statistical expertise within the organisation. The adaptation of the GSOPs into working SOPs should be carried out to reflect the structure and expertise of the organisation.

The GSOPs address the most common requirements of statisticians practising in the field of clinical research. The areas covered are not exhaustive. In some organisations it will be appropriate to combine some of the guidelines into one SOP or to divide other guidelines into several SOPs.

The manner in which procedures are implemented is as important as the procedures themselves if the procedures are to be effective within the structure of a particular organisation. SOPs which are properly implemented as part of an overall quality system not only improve the quality of the service or product but also improve the productivity and efficiency of the process. For example, good trial design and good case report form design can greatly improve the quality of the data collected in a clinical trial.

The PSI “Professional Standards Working Party” was set up in May 1990 and was responsible for developing 11 of the following GSOPs over a period of approximately 18 months. The development process included input from many members of PSI through written comments and workshop discussion sessions. The development process has continued since then with reviews and revisions of existing GSOPs, as well as the preparation of new GSOPs. This review process takes place over a two-yearly cycle, and is the responsibility of the PSI Public Affairs Sub-Committee.

The GSOPs and the Royal Statistical Society Code of Conduct are now augmented by other relevant documents such as the International Conference on Harmonisation (ICH) documents on Clinical Study Reports and Statistical Principles for Clinical Trials and the Association for Clinical Data Management (ACDM) Guidelines for Writing Standard Operating Procedures.

For detailed of this guideline please see the below source for more details

Source:

http://www.psiweb.org/docs/gsop.pdf and

http://www.uk-legislation.hmso.gov.uk/si/si2004/20041031.htm