Policies & Procedures
The full SCDM Policies & Procedures Manual, last updated in August 2013, provides a detailed outline of how SCDM operates in a number of key areas.
SCDM defines plagiarism as the reuse of someone else’s prior ideas, processes, results, or words without explicitly acknowledging the original author and source. It is important for all SCDM authors to recognize that plagiarism in any form, at any level, is unacceptable and is considered a serious breach of professional conduct, with potentially severe ethical and legal consequences.
Equally important to the process of recognizing an act of plagiarism is clarifying who shall be responsible for responding to any complaints of alleged plagiarism. These guidelines specify that the person(s) responsible for the specific SCDM publication or program shall be responsible for conducting an investigation and determining if plagiarism has in fact taken place. In order to accomplish this critical task, the responsible person(s) shall discuss the incident with the applicable SCDM committee or taskforce to help make a recommendation on the allegation. Emphasis is placed on ensuring that an unbiased process is followed.
The scope of this document shall include all materials published on behalf of SCDM, which includes (but is not limited to):
- SCDM Data Basics
- SCDM Data Connections
- SCDM Conference Abstracts and Presentations
- Educational Offerings and Webinars
- Good Clinical Data Management Practices (GCDMP©)
The responsible person(s) must also bring these efforts to the attention of the Chair of the respective SCDM committee; both at the beginning of an investigation and after findings have been reached for final approval.
SCDM membership consists of individuals in North America and abroad who support the purpose of the Society – advancing the discipline of Clinical Data Management – and abide by all Society rules and objectives.
Admission to SCDM is granted at the discretion of the Board of Trustees. Annual membership fees apply and said fees are set by the Board. Fees must be made payable to the Society for Clinical Data Management upon acceptance and annually thereafter.
Membership shall include:
- Employees of pharmaceutical, biotechnology and medical device companies who have direct involvement in or direct supervision of Clinical Data Management
- Representatives of third-party organizations who provide support to the industries above, such as contract research organizations, consultants, hardware or software vendors and personnel search and placement firms
- Members of the academic community involved in managing data from clinical trials or those offering or studying educational curricula on the management of clinical information
- Employees of regulatory agencies involved in the management or review of clinical trial data
- Scientific researchers of related disciplines who express a keen interest in data management practices but are not included in the categories above
- Students enrolled in CDM or clinical research courses working toward a certificate or degree at an accredited university
All members have the right to vote in SCDM elections and are entitled to attend and speak at SCDM conferences.
Any member acting on behalf of SCDM may do so only with the express written permission of the Chair of the Board of Trustees.
The Board of Trustees may revoke the membership status of any member whose conduct is judged in conflict with the purpose of the Society.
Membership fees will not be refunded nor prorated. Transfer of membership is only granted to organizational membership holders and will not be permitted for individual membership.
Member Hardship Policy
Members who are unable to pay their dues as a result of unemployment can apply for SCDM’s member hardship waiver.
Code of Ethics
Clinical Data Management is a key component of the development of new medications, medical procedures and medical devices. Clinical Data Management professionals are:
- Committed to following the laws and guidelines applicable to clinical research (including the Declaration of Helsinki), to participate in the protection of the safety, dignity and well-being of patients and to maintain the confidentiality of medical records.
- Committed to creating, maintaining and presenting quality clinical data, thus supporting accurate and timely statistical analysis, and to adhering to applicable standards of quality and truthfulness in scientific research.
- Committed to facilitating communication between Clinical Data Management professionals and all other clinical research professionals; to maintaining competency in all areas of Clinical Data Management; to keeping current with technological advances; and to ensuring the dissemination of information to members of the clinical research team.
- Committed to working as an integral member of a clinical research team with honesty, integrity and respect; and to making, and communicating accountability for, Clinical Data Management decisions and actions within the clinical trial process.
- Committed to maintaining and respecting proprietary knowledge at all levels, to avoiding the use of proprietary knowledge for personal gain, and to disclosing any conflict of interest. To avoiding any conduct or behavior that is unlawful, unethical or that may otherwise reflect negatively on the profession of Clinical Data Management.
- Committed to advancing the profession of Clinical Data Management through the development, distribution and improvement of Good Clinical Data Management Practices (GCDMP©). To aiding the professional development and advancement of colleagues within the clinical trial industry.