Posts tagged research clinic

How To List Clinical Trials On Your PI’s CV

Jan 02, 2013 Leave a Comment ~ Written by Dan Sfera

Today I got a fantastic question re when it is appropriate to list a clinical trial on the CV of a PI (Principal Investigator). Here is the question in its entirety without giving away the identity of the person who submitted it:
“Hi Dan,

I am having trouble finding any type of published guidance on when to list clinical trials on a PI’s CV. I have seen a variety of formats and although some are prettier than others, my main concern is when it is permissible to list a particular trial on the CV. I was told, 5 years ago when I started out as a CRC, that it was okay to list a trial on the CV two years after completion of the trial. But I have never seen this instruction in writing. And why it not permissible to list a current clinical trial? Any suggestions would be appreciated. We are working on updating all our investigators’ CVs and we’d like to know that we are doing it correctly. I look forward to your response.

Kind regards,”

In this video, I provide my opinion on this, and that’s all I can really give because I am not aware of any specific guidelines for this topic aside from perhaps not breaking the Confidentiality of the Sponsor company paying for the clinical trial as well as the investigational medication. Of course, if anyone out there has a more specific answer, just let me know, but I’m pretty sure there is no actual rule for this one, just use your common sense and good judgement.

Posted in Featured, Research Professionals - Tagged cda, confidentiality, cv, principal investigator, study coordinator

IRB Guidance On Social Media In Clinical Trials Is Overrated!

Dec 09, 2012 Leave a Comment ~ Written by Dan Sfera

So Quorum IRB recently released an article which gives some guidance on the use of social media when it comes to clinical research. Due to the fact that the FDA has not released any helpful guidance on this topic, I welcome Quorum’s efforts to clarify the proper use of social media in clinical trials but I think this is all overrated. When it comes to clinical trial recruitment, the initial contact between research site and study participant usually does not involve ANY study-specific content unlesss it’s a traditional advertisement, in which case, social media would not be the ideal platform to distribute this content. Social media works because it does not function off of ads, it functions off of real content that actually produces helpful information for the recipients of the content. Furthermore, it may allow for further communication between the two parties in which case, the clinical research sites can schedule an actual pre-screening visit with the study participant. I argue that the best way research clinics or CRO’s can reach potential study participants is by actually demystifying clinical trials rather than jumping right in to study specific details. The best ways to do this are to promote the types of trials they do and focus on content around those medical conditions, while leaving the study specific details for future contacts between a member of the study staff and the study participant. Let me know your thoughts on this.

Posted in Featured, Research Professionals - Tagged fda, IRB, quorum irb, recruitment, social media, social media guidance

5 Time Consuming Clinical Trial Start Up Activities

Nov 19, 2012 Leave a Comment ~ Written by Dan Sfera

So lately there has been so much buzz around the announcement of pharma companies sharing their Investigative Site databases in order to shorten clinical trial study start up times by getting rid of redundant procedures. This blog post will bring attention to the Top 5 most important clinical trial study start up procedures that exist in my own opinion. While not all of these are redundant, some will perhaps be eliminated as once a year activities as opposed to being required prior to the start of every clinical trial as is currently the case.
1.) GCP/other training- Good Clinical Practice is no doubt required training for any researcher. However, doing this same training for every study is redundant. Once a year GCP training is currently the industry standard, and prior to these collaborations we are discussing above, most researchers are doing several GCP trainings each year.
2.) IRB questionnaires- This is still unclear as to how this will be streamlined, if at all, but every clinical trial needs IRB approval. Most research clinics can use central IRB’s which make the process easier, while others are required to utilize local IRB’s. Check this video on the differences between these two. Regardles of which type of IRB being utilized, IRB questionnaires are time consuming and usually ask the same information study by study, so it will be interesting to see whether this activity can get streamlined once the Pharma collaborations get underway by the end of this year.
3.) Regulatory document preparation- While this activity is study specific and probably can never get streamlined like the previous two activities, regulatory document preparation of the 1572 form, financial disclosure forms, IRB forms, Informed Consents, and gathering plus submitting all the researcher CV’s is required for clinical trial site activation.
4.) Informed Consent Creation- This activity is also study specific and study details such as subject compensation, IRB contact info, emergency 24 hour contact information, etc must be entered by the research site prior to receiving IRB approval and site initiation.
5.) Creating Source Documents- Most of the time, the research site must create the actual forms for which all the required study data will be collected on. This sounds like a simple task, but for anyone who has done any of this, they know it is extremely time consuming. We had a guest blogger write an excellent article on creating source documents here.
While these are certainly not the only clinical trial start up activities, I believe they are some of the most time consuming ones. It is also important to keep in mind that these activities should not be done by the research clinic for free. Tips on how to bill the sponsors for these activities can be found in this video interview.

Posted in Featured, Research Professionals - Tagged collaborations, compensation, gcp, Good clinical practice, Informed Consent Form, informed consents, IRB, IRB's, Regulatory, regulatory documents, site initiation, study start up

When A PI Leaves Your Site

Oct 01, 2012 ~ Written by Dan Sfera

Today’s guest post is written by Stacey Carmody, a clinical research coordinator. It discusses what you can expect to go through from a research clinic’s perspective, when a PI leaves your site for any reason. Thank you Stacey and any others who would like to contribute articles please email me dan@southcoastclinicaltrials.com

When a PI Leaves: Surviving the Transition

-Stacey Carmody, CCRP

I had been a clinical research coordinator with the same principal investigator for over a decade. Then, with little warning, a bombshell was dropped: I learned that this principal investigator was leaving his position at the site.

Aside from all the sad emotions you experience when an enduring professional relationship ends, there is the also feeling of crisis, and the feeling of “What do I do next?” Transitions are not easy. I would like to share what I learned from my experience and give tips for getting through what will be a chaotic period.

Firstly, call a meeting. If possible, meet with your departing PI along with the sub-investigators and other research staff. Come up with a plan about who will assume the role as PI. The quicker you have a new PI in place, the better. Make sure the new PI knows the studies throughly and knows all the responsibilities that come with being a PI. Conducting a study without a PI in place is not only prohibited, but can spell disaster for your participants and anyone else involved. Studies must have PI oversight at all times!

Let the sponsors know. The sponsors of your studies selected your site partly based on your PI’s experience and credentials, so a change in PI is a huge deal to them. You want to let your sponsors know right away about the change in PI and you must be willing to supply any information they want to know about the new PI (CV, licence, clinical trials experience, etc) . They will need to give their approval for the new PI. If the sponsor approves the new PI, get the approval in writing, as you’ll need to give this to your IRB. Work with the sponsors to get the appropriate regulatory paperwork changed from the outgoing PI’s name to the new PI’s name. Many papers will need this change such as the contract, the 1572, the consent forms and central lab reports. The delegation logs in your regulatory binders will have to reflect the change in PI as well. And, of course, your study subjects will need to be informed of the change.

Contact your IRB. When I got the news that my PI was leaving, I contacted my IRB the next day. I needed to know what kind of paperwork I had to submit . If your outgoing PI needs to sign any IRB paperwork, if possible, obtain the signatures before he or she leaves. Also, if possible , obtain a signed letter from the outgoing PI denoting the date of departure from the site, the reason for departure, and the date the new PI took over. If it is not possible to get a letter , then make a note to file with this information. It is important that you document that the studies have oversight from a PI and that there is not a “gap” between PI’s when the studies are in progress.

Meet with the new PI often. This will be a transitional for him or her, and we all know how much PI’s depend on us coordinators! Be there to help with any questions regarding the conduct of the studies and keep the PI abreast of any communication from the sponsors, and set up meetings with the study monitors/CRA’s so communication will flow and the transition will go smoother.

Lastly, don’t panic. And have a plan. I know that is easier said than done! But keeping calm and focused makes a big difference. It also helps to have a plan in place in case your PI leaves unexpectedly. Even if your PI seems like a permanent fixture, you never know when life will throw a curve. It is a good idea to keep a list of what steps to take and who to contact. Preparedness makes all the difference. The dust will settle in time.

Posted in Featured, Research Professionals - Tagged business, ethics, physician, principal investigator, study coordinator

Renegotiate A Clinical Trial Budget

Jul 27, 2012 ~ Written by Dan Sfera

Today’s video is in regards to clinical trial budgets, and your power as a research clinic that has performed well on an existing study, to renegotiate the budget for better terms. In particular, the screen fail reimbursement ratio should be examined, and if appropriate, renegotiated for better terms. In this video, I explain this and more topics in greater detail. Let me know if you found this helpful!