What’s the Experiment? (Protocol Review)
March 17, 2020
OVERVIEWFoundational information regarding what constitutes a good clinical study in relation to regulations, and the incorporation of basic scientific and ethical principles will be discussed. The introduction of the Scientific Method will be presented and compared to the components of the protocol.
Protocol elements and descriptions will be presented to learners so that they may understand the components of the document and the rationale identified. Examples of different sections of a protocol will be offered and finally there will be an outline for the CDMs strategy to protocol review and how to utilize the content to assist in data collection instruments for final data analysis.
WHAT YOU'LL LEARN
At the conclusion of this seminar attendees will be able to:
- Explain the scientific method;
- List the elements of a protocol;
- Describe the elements of the hypothesis;
- Identify endpoints;
- Differentiate between protocol amendments, deviations, and violations.
WHO SHOULD ATTENDThis webinar will be beneficial to Beginner and Intermediate CDMs
WHAT ARE THE BENEFITSParticipants will benefit from this webinar by having a better understanding of the scientific method and how this provides a basis for the protocol in defining the clinical trial. Incorporating a protocol review strategy will benefit the attendee in becoming more proficient in identifying data collection requirements.
MEET THE PRESENTER
Denise G. Redkar-Brown, MT,began her career as a Medical Technologist working in a hospital laboratory environment. She made the transition to the pharmaceutical industry, and after more than 25 years she has held positions in basic and clinical research as well as creating and facilitating training for Barnett International for the past 21 years.
She is published in the European Journal of Pharmacology for her work in pharmacology while at AstraZeneca, and was published in the Good Clinical Practices Journal in 2008. More recently she has been a contributor to the Good Clinical Practice Question and Answer Guide (Barnett International) and is co-author of the chapter on Selecting an EDC Application in the Good Clinical Data Management Practices (GCDMP) published by the Society of Clinical Data Management.
Denise has contributed to the successful submissions for Accolate® (the first leukotriene antagonist for asthma therapy) and Seroquel® (Serotonin receptor compound for treatment of Schizophrenia and bi-polar disorder). Denise also worked at Dupont Pharma (Immunology), Knoll (Humira®), Sanofi-pasteur (vaccines).
Denise established a successful Clinical Data Management department at a CRO in North Dakota, and is past chair for the Educational Committee and past Board member for the Society of Clinical Data Management (SCDM).
Currently Denise resides with her husband, Lee, in Elkton, Maryland and is the Principal for Sunburst Clinical Solutions.
Travel, genealogy, reading, antiques and grandchildren are some of the hobbies that she enjoys.
EARN CEUsParticipants are eligible to receive CEUs upon attendance and successful completion of a web-based assessment within 30 days after the webinar. CEUs are not granted after the 30-day assessment deadline.
SCDM is authorized by IACET to offer 0.2 CEUs for this program.
|Group (max. 10 ppl.)||$960||$1,140|
Group Registration Policy: Any group registration allows up to 10 people to attend the webinar and to complete the webinar assessment. Credits will be granted on an individual basis upon successful completion of the assessment by the registered participants.
Refund Policy: Participants will receive a full refund if notice is provided in writing via post or email one week prior to the webinar date. If cancellation occurs within the week prior the webinar, participants will be allowed to apply 50% of the webinar fee to the next offering of the same webinar. No refunds will be offered after that time.
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