U17BTT7002 PRECLINICAL AND CLINICAL REGULATORY AFFAIRS

Semester: 7 | Date: 23/September/2020 | Assignment – Synchronous Session (Graded)

CONSORT DIAGRAM FOR FICTIONAL FACTORIAL STUDY DESIGN WITH MARVISTATIN

CONSORT DIAGRAM FOR FICTIONAL FACTORIAL STUDY DESIGN WITH MARVISTATIN

RAGHUVANDHANAN K S | 17BBT002
TERMINOLOGIES
NYHA - New York Heart Association (NYHA) Heart Failure (HF) Classification
1. CLASS III - Marked limitation of physical activity. Comfortable at rest. Less than
ordinary activity causes fatigue, palpitation, or dyspnea.
2. CLASS IV - Unable to carry on any physical activity without discomfort. Symptoms of
heart failure at rest. If any physical activity is undertaken, discomfort increases.
3. RUN IN - A period of time prior to enrollment during which study candidates are
placed on a treatment similar to one being evaluated to assess tolerance or
acceptance, or to provide information on treatment compliance.

REFERENCE:
1. https://prsinfo.clinicaltrials.gov/trainTrainer/Factorial-Design-Answer-Key.pdf
2. https://prsinfo.clinicaltrials.gov/trainTrainer/Factorial-Design-Fiction-Manuscript.pdf
3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3125670/
4. http://www.consort-statement.org/consort-statement/flow-diagram

The consort diagram for frictional factorial study design with marvistatin was done using
Google docs.

RAGHUVANDHANAN K S | 17BBT002