A Day in the Life of a CTA by Helen and Jan
The role of a CTA is mainly office-based and every day there are different issues to contend with. The job requires a good eye and attention to detail as there is a lot of reading, researching and checking. It can be very time consuming with the printing and sorting alone, before you even begin to do your filing, checking and cross-referencing. It is very difficult to put a timescale on a particular job, as this often depends on how much paperwork is involved, not only with the Trial Master File (TMF), but with emails and attachments, so it can sometimes take up to 2 – 3 hours just to print off documentation before you even start to collate and file. So here is an idea of the type of things a CTA will be asked to do, during the course of a day.
We arrive at the office and start the day by downloading emails. Depending on the study you are involved with these can number from 2 to well over 100.
10.00 am until 12.30 pm
This time is taken up with reading, checking for any actions to be dealt with, separating documents into the appropriate client file and then printing. We then check all the emails are in correct date order and separate any attachments ready for filing in the TMF. All documents/emails have to be filed (however small) to make sure an audit trail is maintained.
12.30 pm lunch
All prepared by our own fair hands and healthy of course!
1.30 pm onwards
We keep all our TMF's in very secure stronghold cupboards that are fire proof and kept under lock and key. The TMF is the central repository for all essential documents required for a clinical trial. We follow the ICH GCP guidelines and have an “essential documents” checklist set up, so that all documents can be recorded against the checklist. This is a tool used for checking what is still required/missing from the TMF and makes life easier for both the CTA and the Clinical Research Associate (CRA), who normally visits sites for monitoring of the study. The CRA can then check against the Investigator Site File, to make sure the essential documents are also present at sites, and to cross check with the TMF.
We liaise with the Project Managers (PMs) and/or CRAs on a regular basis to clarify any issues and make sure they are aware of any missing documents that need collecting from site to be filed in the TMF.
We also liaise with the client on any issues for example, checking/retrieving information from the TMF related to patient screening/enrolment forms. We send the required documentation out and make sure a document transfer form is returned to us to confirm receipt.
From time to time we are asked to organise and attend Investigator Meetings, which can involve organising transport and accommodation for all, booking the venue and taking minutes and distributing after the meetings, amongst numerous other tasks.
Off to our families and to our 2nd jobs at home!!!