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: ALCOA, ALCOA Checklist
While good organizational skills may present a challenge to many of us, allowing disorder to follow us to work is simply a recipe for disaster. Not only can disorganization create for a hectic day, it can also lead to larger problems with industry compliance standards and FDA approvals. Whether your company is involved in drug trials or device studies, poor organization can leave your site more vulnerable to non-compliance if risk-based monitoring is used. It can also create an unpleasant environment during an FDA audit if there are issues with a Sponsor or site’s compliance with ALCOA (attributable, legible, contemporaneous, original, and accurate) guidelines. (Please refer to our ALCOA infographic for more information.)
Topics: ALCOA, Compliance, Organization
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.
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)
Good Clinical Practice is the cornerstone for conducting clinical studies. However, as clinical research professionals we should strive to take “good” to “great”. This requires having historical perspective and a firm understanding of GCP requirements, but it is equally important to know how to properly document authentic research observations.
Topics: Good Clinical Practice, ALCOA, 21 CFR 58.130 (15)
Well it’s no secret that our industry is a fan of acronyms. Acronyms are widely used as helpful mnemonic devices to remember important or useful information. And, let’s face it- from examples like ALCOA to FAIR Shake, they’re just too good to stop using! Here’s another to add to the list that revolves around monitors.
Topics: ALCOA, Good Monintor, FAIR Shake, Acronyms
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, ALCOA, Document Your Work