Lead CRA Q&A: Sponsor Furnished Source Documents

Source Documents in clinical trials Anonymous commented in… “Perfect Clinical Trial Source Documents“: Hi, some sponsors don’t allow investigators to use source documents in clinical trials such as data worksheets/templates arguing that source data should not contain instructions nor any other items (logo, etc.) which would not usually appear on a patient medical file.  Is there…

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Every Email is an Essential Document…or perhaps not

every email is an essential document

Wait, you said I shouldn’t file every email? Please, no, for the love of all that is Holy, don’t file every email. I currently manage 15 sites and as a general rule, only about 1 in 10 emails I generate end up in the correspondence tab. This is because I do a lot of back-and-forth…

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Site Master File: Correspondence

clinical trial site master file secure

The Site Master File (SMF) or Regulatory Binder contains all of the essential documents to provide a record of study conduct. The SMF when reviewed with the clinical charts and archived study materials allows sponsors, auditors, regulators, and all other interested parties to reflect back on a clinical trial and understand how things were conducted,…

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Motivating your Study Coordinators

As monitors, we rely on the Study Coordinators (SC) to assist us in site management activities like record-keeping and re-supply. We ask them to keep us informed of progress at the study site through reporting, screening/enrollment logs, issue identification, etc. We have them prepare the CRFs, complete data-entry, attend trainings, review newsletters/correspondence/memos, answer emails, fax…

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Perfect Clinical Trial Source Documents

Perfect clinops tooklit source

As a CRA, I regularly visit the sites to review the study conduct, encourage study participant recruitment, evaluate the ongoing suitability of the investigative site, provide protocol specific training, track investigative supplies, and to review source documents.  Clinical Trial Source documents are the roadmap and clinical record to let me (or anyone who is reviewing)…

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What is up with this coordinator?

understanding your study coordinator

How can we motivate? In a separate post I provide you tips and advice for motivating and working well with your coordinators. However, sometimes it is hard to get a Study Coordinator to answer the phone, email, or query requests.  Other times they are behind on their Screening/Enrollment logs, supply requests, data entry, etc.  As a CRA…

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Investigational Product Accountability

properly consent subjects before dispensing investigational new drug

Clinical trials are conducted for new investigational products and also to explore additional endpoints/indications for marketed products or combinations.  The medication dispensed in the clinical trial is governed by country/local requirements and strict regulations dictating that it must be tracked and accounted for throughout conduct of the trial.  There are also regulations regarding how the…

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Selecting Qualified Investigators

The focus of this post will be selecting adequately performing US clinical trial sites for Investigational New Drug studies.  Depending on the nature and size of your clinical trial, you may be targeting private practices, specialists, academic centers, purpose-built dedicated clinical research facilities, or a combination of any of these to find your principal investigator(s)…

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New Year, New Destinations, New Perks?

a new year of travel and perks for The Lead CRA

I’m out on my first work trip of the year performing a few Site Initiation Visits for a new drug study in Southern California.  I’ve definitely logged some serious miles flying SFO->LAX in my time monitoring but hopefully I’ll have more sites soon in some locations that are new to me (but not anywhere it…

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ICON Warning Letter from the FDA

keep the investigational medicinal product secure in a clinical trial

Please check out a recent warning letter sent to ICON Clinical Research in regards to monitoring services they provided for two antibiotic trials. Routine Inspections Triggered Serious Findings My understanding is that the sponsor submitted the NDA, triggering routine inspections, and the CRO has now been asked to respond to a series of serious findings. …

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