Testing of New Drugs

¶ … Flow Diagram

The author of this report has been to assess a data flow diagram that makes reference to clinical trials. For each step in the clinical trial, the author of this response will speak to what personnel would be involved with that step of the process. Indeed, the data flow diagram in question is seventeen steps long and the litany of personnel involved with each step can be moderate to extensive. While some may think that clinical trials are fairly mundane and easy to pull off, that is simply not the case and the process is indeed extensive and potentially circuitous depending on how things go (FDA, 2016).

Questions Answered

Step one of the diagram involves protocol development. The personnel involved would include medical writers, physicians, medical experts, project managers, biostatisticians and data managers. The protocols and rules of the study are important and must be defined. Step two is protocol to systems conversion. People involved would be programmers, systems support staff, data managers, project managers and CRA's. The systems involved must be created, converted and meshed. Step three is CRF development and would include data managers and project managers. CRF's are case report forms and must be made in the right way to get the best and accurate information. Step four is site selection and activation and includes regular staff, project managers, CRA's, clinical support staff and site staff. Of course, the site(s) used are important and must be picked correctly. The fifth step is the data management plan step and this would include project managers, data managers and biostatisticians. The management of data integrity, accuracy and backup must all be managed to keep the data safe and applicable. Step seven is the statistical analysis plan and this would include statisticians, medical writers and project managers. This is important because the way of looking at the data must be defined in advance. Step eight is project enrollment and would include investigators, study coordinators, CRA's and project managers. Getting the right people in study is important for obvious reasons. The ninth step is safety even reporting and management and this would include data mangers, study coordinators and investigators, just to name a few. There are also safety managers and pharmacovigilance team members. Safety is a big issue when doing trials like this.

The tenth step is clinical data collection and this would include study coordinators, clinical subjects, CRA's, lab personnel, investigators and project managers. Now that the data collection has been planned, it must actually be collected. The eleventh step is medical and safety coding and this would include data managers, project managers, study coordinators, CRA's and investigators. This is important so that the data is summarized and classified correctly. The twelfth step is data review and cleaning and this would include CRA's, data managers, study coordinators and investigators. Medical monitors may also be included. The thirteenth step is database lock and this would include data managers and project managers. Data analysis, the fourteenth step, includes biostatisticians, medical writers and regulatory affairs personnel. These last two steps matter because the steps must be looked at properly. The fifteenth step is regulatory submission and this would include regulatory personnel and project managers. Doing data submission to agencies by the book is an obvious must with clinical research trials. The sixteenth step is study progress monitoring and this would include CRA's, data managers, programmers, pharmacovigilance and investigator personnel. The milestones of the study must be tracked and looked at. Finally, the seventeenth step is data pooling and would include project managers, programmers and data managers. Assembling the data properly and timely is a must as well.