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.
Clinical research professionals have an obligation to uphold the highest ethical standards and make all possible efforts to comply with Good Clinical Practice. Proper documentation is of the upmost importance in our work! .
Topics: ALCOA Checklist, ALCOA-C
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
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: 21 CFR 58.130 (15), ALCOA Checklist, FDA
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, Federal Regulations, ALCOA Checklist
The terms Essential Documents, Investigator Binder or Study Binder are sometimes used interchangeably. For all clinical research trials involving human subjects, there must be a file maintained by the Sponsor and the Investigator containing all the necessary paper work to support the clinical trial and could be called any of the above-mentioned names. During an onsite review of study records by an IMARC monitor, essential documents are reviewed to ensure that they are present, accurate, complete and current by following the ALCOA checklist and as specified in the FDA regulation 21 CFR 812.140.
Topics: FDA Regulations, ALCOA Checklist, Delegation Log
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, ALCOA Checklist, IMARC Research