You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
When documenting your research observations, it is important to remember the adage, “If it wasn’t documented, it wasn’t done”. As research professionals, we have an obligation to uphold the highest ethical standards and make all possible efforts to comply with Good Clinical Practice. We must take credit for what we do - and to take credit for what we do, we must properly document our work.
Topics: Research Professionals, 21 CFR 58.130 (15), FDA Auditors, ALCOA Checklist
When documenting your research observations, it is important to remember the adage, “If it wasn’t documented, it wasn’t done”. As research professionals, we have an obligation to uphold the highest ethical standards and make all possible efforts to comply with Good Clinical Practice. We must take credit for what we do - and to take credit for what we do, we must properly document our work.
Topics: Good Clinical Practice, Research Professionals, ALCOA, 21 CFR 58.130 (15)
A checklist can act as a “road map” for a monitor performing a study site visit. What better way to track what has or has not been done and what important questions need to be asked then by using the sometimes forgotten but always reliable checklist? A well prepared checklist results in a greater likelihood that the sponsor’s goals for a visit will be met. A checklist can also be used as proof that certain tasks were accomplished.
Topics: Research Professionals, The Checklist Manifesto, Checklist