Blogs

IATA Training

By Tanya Powell posted 08-25-2012
4 people like this.
Hello, Can anyone tell me where I can find a reputable and approved free website to do IATA training. Thanks, Tanya
2 comments

Is it ok not to report an SAE within 24 hours

By Jennifer Elston posted 08-25-2014
3 people like this.
I know, I know all SAE's should be reported in 24 hours, but I had to say something to get your attention :-). Seriously though! If you have a PI that is a hospitalist (makes rounds at the hospital), and he admits a subject to the hospital (true SAE) on Saturday. Is he required to report the SAE by Sunday if his office doesn't open until Monday morning? Should he carry SAE forms for all studies in his car just in case? This has come up in an audit, and I am not sure how to respond. Thanks for the help! Jennifer
3 comments

Free CEU

By Karen Willis posted 08-20-2010
1 person likes this.
Thank you for sending out this notice for the free CEU; I would have missed. I feel at times I am being nicholed and dimed (dollared $$$$) trying to keep up with CEU requirements for ACRP certification and nursing along with the certificatin fees! It is refreshing to occasionally get a break from dishing out $$. Thank you, Karen
1 comment

IATA Training

By Robert Keene posted 12-30-2010
1 person likes this.
Does anyone know of some good, inexpensive, reputable online IATA Training? Thanks!
3 comments

Monitor Experience Advice

By Meghan Miller posted 09-25-2009
1 person likes this.
I have been in the Bio-Tech/ Pharma industry for over 3 years and done in house monitoring and project management for Clinical Operations. I have much in-house experience , though would like to move into field monitoring, which I am very confident that I have the skills and regulatory knowledge. How do you break into field monitoring without the out of corporate experience?
3 comments

What's in a name

By Deborah Jones posted 03-03-2015
1 person likes this.
Does my signature have to be the same as my legal name on clinical research regulatory documents?
2 comments

A Funny Thing Happened On My Way To Clinical Trials......

By Jeff Thetford posted 07-03-2014
3 people like this.
Being a fledgling research coordinator for a big retina practice has shown its challenges. Coming from a background of transplant work with a local Eye and Tissue Bank (ten years of collecting eye tissue for transplant and dissecting full body donations for scientific research) and ten years of working in a clinic environment set a good foundation for clinical knowledge but has done little in the way of readying me for work in clinical trials. Being a 'people person' has helped in getting information from people to answer just about any question I have when it comes to protocols, CDA's, NDA's, AE's, SAE's and so on. But it just has not been enough. When ...
2 comments

Salary range for RN Research Coordintators

By Margaret Knack posted 07-25-2014
1 person likes this.
I have less than one year's experience as a Research Nurse Coordinator and my annual salary is $62,500 in Germantown, TN.
2 comments

What's it like to live and work in Portland, OR?

By Olivia Derridinger posted 07-18-2013
2 people like this.
Hello! My husband and I are contemplating a move to Portland, OR, what is it like to live in Portland OR? Is the job market good for clinical research or hospital administration? Thoughts? Comments? Favorite places to visit, eat, shop? Thank you! Olivia Derridinger, MPA/Health, CCRC
2 comments

Start Up Your Own Community

By Jeremy Glunt posted 07-22-2010
1 person likes this.
Interested in starting your own community? CRCs in Uganda? CRAs who like badminton and cups of tea? You can literally start any community you want; and you can decide whether you want that community to be available to anyone who wants to join, or whether you want that community to be invite-only. Here's how to start a Member-Created Community: 1. Under the 'Directory' tab, click 'Communities' 2. Click 'Create a New Community' 3. Enter the attributes of your new community (name, description, etc.) 4. Decide whether you want the community to be invite-only or open to anyone who wants to join. 5. Decide whether you want the community to have an ...
2 comments

Oncology Clinical Trial Nurses- a Doctoral Survey!

By Carolynn Jones posted 12-23-2015
1 person likes this.
I am posting this on behalf of Michelle Purdom, a colleague of mine who is doing her doctoral research on oncology clinical research nurses. Please consider participating if you fit the bill: If you are a nurse who is currently working in a position that is primarily focused on providing direct patient care to oncology clinical trial patients OR that is primarily focused on coordination aspects of oncology clinical trials OR a combination of both, you are eligible for participation in this study. This survey is part of an IRB approved research study to determine the activities performed by oncology nurses whose primary responsibility is direct (example: ...
1 comment

Research Staffing

By Sonya Mathewson posted 01-22-2013
1 person likes this.
Does anyone know of a national standard for research coordinator staffing?
1 comment

Risk Based Monitoring Experience?

By Madelaine MacKay posted 08-09-2014
1 person likes this.
Hi, I am a Clinical Team Manager based in Canada and am currently working on a dissertation towards completing my MSc in Clinical Research with the University of Liverpool in the UK. My topic is the impact of risk based monitoring (RBM) strategies on industry sponsored trials. I am looking to have 40-50 individuals working in various clinical research roles for pharmaceutical and biotech companies complete a short (5 min) survey monkey on their experience and perception of risk based monitoring practice. The link to the 10 question survey is as follows: https://www. surveymonkey.com/s/RBM_SURVEY If you are able to take a few minutes to ...
1 comment

SEFL ACRP Chapter

By Deena Bernstein posted 06-23-2010
1 person likes this.
We are all so excited that this new chapter has come to fruition! After many months of meetings and going through the stringent application process this group is ready to help make this chapter a success! I hope that all the research professionals in the Dade, Broward, and Palm Beach area will join the group and bring their friends so that we can share valuable knowledge and experience that we each uniquely have acquired through our clinical research endeavors. For more information on how to get involved and join please e-mail me at dbernstein@shcr.com On behalf of the Board of Director's we look forward to meeting all the new members. Deena Bern ...
1 comment

India the second time around

By John Hills posted 12-08-2010
2 people like this.
Today begins my blog about everything I experience during my work-related travels. I'm hoping that my blog entries serve two purposes: to record my experiences in a central location to view over and over again, and to share my experiences so that my fellow clinical research colleagues can have a reference in case they find themselves in the same places I have gone. Here goes nothing... I am in India for the second time this year. The first time was in July. If you can avoid it, do NOT go to India in July unless you like sweating buckets. The humidity is stiffling. (And I thought Houston was bad during the summer.) Back then I went to New Delhi, Nagpur ...
1 comment

Ongoing Review of Studies by IRB/ECs

By Ashish Rastogi posted 04-30-2011
1 person likes this.
Would like to know the experiences with Ongoing review of studies by EC/IRB's. How often/frequently do you know EC/IRBs to do this? 2. In your opinion/knowledge - do they seek only periodic progress report or d o some of them sometimes arrange to visit the sites / see records for the ongoing overview? 3. What is the system/method/perspective by which the EC/IRBs usually review the SAE reports? 4. Does the EC/IRB meet specifically to review the SAE report or does it take up the report for review only during the next scheduled meeting (which may be 1-2 months away)? 5. Does EC/IRB also review the opinion of Investigator regarding causality ...
1 comment

Tired of Having to Log In to Respond to an eForum Message?

By Jeremy Glunt posted 12-15-2008
1 person likes this.
You might have noticed by now that you are required to log in to the ACRP Online Community when trying to respond to an eForum message directly from your email account. If you would like to bypass this requirement, all you need to do is visit the My Subscriptions page and change your subscription type to PDA for any and all eForums for which you'd like this option. This will allow you reply to an eForum directly from your email WITHOUT have to log in to the Online Community. It should be noted that this option will deliver text-only messages to your email, and responses cannot include attachments. This is for security purposes in cases of emails forwarded to ...
1 comment

Payment for screen failures

By Lisa Gordon posted 09-23-2014
2 people like this.
I have found that Sponsors use the screen failure payment limit as a safety net so that they are not paying out random screenings and being taken advantage of. I think it forces a more careful pre-screening process and usually they provide an IRB approved pre-screening script to aid in that process. If the Sponsor or CRO did not provide an approved pre-screening script, I would certainly ask for one.
0 comments

Smarter Monitoring

By Meredith Mundy posted 03-17-2014
1 person likes this.
I have been working with a company called Patient Profiles for the last few months, and really wish I had found them earlier. I am really quickly becoming a bigger and bigger fan of the software, particularly as I delve more into Risk-Based Monitoring. So please excuse the shameless plug, but some things are just too good not to share. Last week, I sat in on the ACRP sponsored webinar "FDA/EMA Inspection Lessons: How Adequate Monitoring Can Reduce or Avoid Findings". The main focus was on warning letters received by Investigators, Sponsors (and/or CROs), and IRBs and how better quality monitoring could have mitigated or avoided the warnings all together. ...
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ACRP - Monitor Magazine - December 2009 - The Future of Clinical Research

By Al Pacino posted 11-30-2009
1 person likes this.
A s we look to the future, we find ourselves amidst tremendous opportunities for change in the clinical research enterprise. In the December issue of The Monitor, we will hear from some of the “thought leaders” who are at the cutting edge of new and improved approaches within clinical research. These approaches are currently being bridged by new technologies that, only a few years ago, would not have been able to exist without the innovative mixing of mainstream services that was once viewed by our industry as being too difficult to accomplish. In the December issue of The Monitor, we will hear from some of the “thought leaders” ...
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