|or||The Dog Ate My Dissertation . or, Post-Graduate Qualifications in Clinical Data Management|
|The Team of 1999|
|The ACDM Academic Sub-Committee (ASC) is responsible for working with the ACDM and Kingston University to ensure the continued delivery of the MSc, Certificate and Diploma programme. This year, due to career commitments, Anne Galer (Chair) who has been on the committee for 6 years and Sue Snape (Secretary) with 4 years service, are leaving their posts. The Academic Sub-Committee would like to hear from ACDM members who would be interested in joining this exciting group (see contacts at the end of this article)|
|In the beginning was the word and the word was .. DIPLOMA!!! By 1993 the Diploma Sub-Committee had formed as a separate sub-committee from the original Training Sub-Committee following research into the demand from ACDM members for a post-graduate qualification in Clinical Data Management. To remind you all, 2 questionnaires were sent out and there were 147 responses from the first, with 80% of the responders expressing an interest in attending such a course. The second questionnaire was aimed specifically at managers. Replies came from 47 companies, representing 480 staff involved in CDM, indicating that approximately one third of their staff would be potential course delegates.|
|After contacting 21 universities, early in 1994 Kingston University was selected to provide the course, which was extended to a full Masters programme. The remainder of the year was spent finalising the aims and objectives of the course and beginning the Validation Process, which was completed in the first half of 1995. During the accreditation, the Validation Panel recommended that steps be taken to ensure that the course was appropriate for wider access (i.e. to include entry for those individuals without prior formal qualifications). This is a feature that remains a central aspect of these qualifications. The first module was successfully run in September 1995 and since then a total of 106 students have enrolled on the course.|
|Currently there are 53 students registered on the course with 42 students taking modules during the 1999-2000 session.|
|Thirty three companies have supported their staff (over the years from 1997 to 2000) going through this programme.|
|Fifteen students have elected to complete their studies by claiming a PgCert (10) or PgDip (5). Congratulations to all.|
|The titles of past MSc projects|
|To give you some idea of the variety and scope of the projects that have been submitted for MScs here are the titles from 1998 and 2000:|
|1||A fast and flexible process to ensure the successful delivery of quality clinical trial databases to the sponsor where the data management is outsourced to a CRO.|
|2||The development of an integrated safety database for a multi-market, OTC Medicinal Product.|
|3||An investigation into the effectiveness of data validation during clinical trials and the methods by which it could be improved.|
|4||The use of electronic data capture in clinical investigations.|
|5||Developing a theory, model and methodology based on data state transitions to be used as a basis for designing and optimising a clinical data management process.|
|6||The introduction and testing of a new clinical data management system.|
|7||An overview of the current status and future perspectives of the impact of the International Conference on Harmonisation Good Clinical Practice (ICH GCP) Guidelines on clinical trials conducted in Japan.|
|8||An investigation into the methods used for serious adverse event reconciliation in the pharmaceutical industry.|
|9||An analytical assessment of resource utilisation in clinical data management.|
|We meet about 4 - 6 times a year planning the academic year, documentation review, marketing activities and this year we are embarking on a review of the course structure and associated re-validation. Peter Soan, the Course Director from Kingston University, joins us for our meetings so we are able to work closely together on course improvements.|
|September is a busy month for us as the MSc Dissertations are marked, the project proposals for the following year are reviewed and with the start of the next academic year ahead we have course dates and new marketing materials to publish.|
|Bharat Ruparelia has replaced Anne Galer as the ASC Chair and Geraldine Smith replaces Sue Snape as Secretary.|
|What do we do?|
|Deal with some aspects of course administration including enquiries, course promotion, maintaining professional standards, keeping the qualification relevant to current industry practices.|
|Review MSc Proposals and provide constructive feedback for students.|
|Liaise with Kingston University who run the course on our behalf.|
|Liaise with the Module Leaders to ensure training plans and presentations of the experienced industry personnel meet the objectives of the course and the respective modules.|
|Arrange for publicity of the forthcoming modules to ACDM members.|
|Review consistency and quality of course materials in conjunction with the Course Director and much, much more!!!|
|What do we get out of it???|
|Seeing the development and maintenance of academic qualifications and university courses and how students perform.|
|Enjoyment in reviewing project proposals and ultimately seeing the end result, the MSc dissertations themselves.|
|A new experience by being involved in the marking process.|
|Seeing the variety of industry practices.|
|Interesting work via continuous review and proposing course improvements.|
|The knowledge that people are gaining qualifications that will benefit Clinical Data Management and the student personally.|
|The guidelines for MSc courses were recently reviewed. As a result, the need to revalidate the post graduate qualification courses was identified. This process has now started and is expected to be completed in June 2001. This will mean that the new courses will start in September 2001. The main changes will be a reduction in the number of modules required to achieve the various qualifications. In addition the number of hours allocated to study will be brought in line with other comparable industry-related courses.|
|The Academic Sub-Committee is increasing the awareness of the benefits and course contents in a number of ways:|
|You may see members of the Academic Sub-Committee presenting further details of the post-graduate qualifications at your ACDM course.
|You can visit our web site www.acdm.org.uk under the Activities tab, SCs, ACADEMIC.|
|We will be attending more of the individual modules to ensure that the course content reflects the changing requirements of our industry.|
|We plan to have a stand at the 2001 ACDM e-conference in February where you can speak to students (past and present), Modules Leaders and ASC members.|
|The following list of phrases and their definitions might help anyone writing a dissertation or academic paper... or maybe not|
|IT HAS LONG BEEN KNOWN
I didnt look up the original reference.
|A DEFINITE TREND IS EVIDENT
These data are practically meaningless.
|WHILE IT HAS NOT BEEN POSSIBLE TO PROVIDE DEFINITE ANSWERS TO THE QUESTIONS
An unsuccessful experiment but I still hope to get it published.
|THREE OF THE SAMPLES WERE CHOSEN FOR DETAILED STUDY
The other results didnt make any sense.
|TYPICAL RESULTS ARE SHOWN
This is the prettiest graph.
|THESE RESULTS WILL BE IN A SUBSEQUENT REPORT
I might get around to this sometime, if pushed/funded.
|IN MY EXPERIENCE
|IN CASE AFTER CASE
|IN A SERIES OF CASES
|IT IS BELIEVED THAT
|IT IS GENERALLY BELIEVED THAT
A couple of others think so, too.
|CORRECT WITHIN AN ORDER OF MAGNITUDE
|ACCORDING TO STATISTICAL ANALYSIS
Rumour has it
|A STATISTICALLY-ORIENTED PROJECTION OF THE SIGNIFICANCE OF THESE FINDINGS
A wild guess.
|A CAREFUL ANALYSIS OF OBTAINABLE DATA
Three pages of notes were erased when I knocked over a glass of beer.
|IT IS CLEAR THAT MUCH ADDITIONAL WORK WILL BE REQUIRED BEFORE A COMPLETE UNDERSTANDING OF THIS PHENOMENON OCCURS
I dont understand it.
|AFTER ADDITIONAL STUDY BY MY COLLEAGUES
They dont understand it either.
|THANKS ARE DUE TO JOE BLOGZ FOR ASSISTANCE WITH THE EXPERIMENT AND TO CINDY ADAMS FOR VALUABLE DISCUSSIONS
Mr. Blogz did the work and Ms. Adams explained to me what it meant.
|A HIGHLY SIGNIFICANT AREA FOR EXPLORATORY STUDY
A totally useless topic selected by my committee.
|IT IS HOPED THAT THIS STUDY WILL STIMULATE FURTHER INVESTIGATION IN THIS FIELD
|And finally Postgraduate Courses Beat Fuel Crisis|
|The Assessment Board meeting for the Postgraduate Courses in Clinical Data Management was held at Kingston University on September 15th 2000 - in the midst of the fuel crisis (and torrential rain).|
|Special thanks are due to those lecturing on the courses who made exceptional efforts and managed to attend the meeting under very difficult circumstances: Mr D Crinall (GlaxoWellcome), Mrs G Francis (Kingston University), Dr R Kay (Parexel), Mr T Pascal (GlaxoWellcome), Ms C Godwin (GlaxoWellcome), Dr D Tsaptsinos (Kingston University) and Dr C Webb (Amgen - external examiner).|
|Thanks are also due to those who provided their comments to the meeting in writing and those who made themselves available for telephone contact. Their efforts permitted the students marks to be ratified and qualifications (including 4 MScs) to be awarded in time for graduation this year.|
|Outgoing Chairperson, ACDM Academic Sub-Committee|