On a site initiation visit recently, a member of the Harte Group team accompanied an experienced, seasoned Contract Research Associate (CRA) to an academic site. The physician was extremely busy and had previously arranged a 30 minute block of time to receive instruction, answer questions, etc. I had inquired about the use of a checklist, something to help ensure that all tasks would be performed during the visit. The experienced CRA mentioned that this task had been performed so many times before that it could be done in her sleep. Upon sitting down in the conference room, the usual white out, post-its in multiple colors, and other support materials were all displayed on the table, along with many paper forms/copies for our meeting. An extra piece of luggage had been brought along, as it contained the study binders and other materials for the staff. For 2 hours, the meeting flowed extremely well, with papers and guidance documents being distributed, binders being presented. During the brief time with the physician, instruction and protocol discussions ensued, with the physician demonstrating that he had read the protocol thoroughly, the indication and study drug was of great interest and showed a few folders of patient candidates already contacted – really terrific. He was busy, had to leave, is there anything else? The response for the CRA was no, was courteous in thanking him and off he went to fulfill multiple other duties.
During the final piece of the initiation with the coordinator, the CRA noticed that she failed to receive the investigator signatures and absolutely needed to see him. The coordinator tried to locate him, but he could have been anywhere – for 2-1/2 hours, we attempted to track him down – finally catching him at an adjacent building between patient visits to receive the signatures.
So, what is the impact of a failure to use a guidance document or electronic forms?
The impact was that the CRA missed her flight, being charged for changing planes and now having a 5 hour delay at the airport. When weather caused additional delays, she opted to fly to a different airport and drive to her home for an important family event – understandable. She arrived safely.
How did this effect the Harte Group and our sponsor? The CRA was an hourly-rate person, so the meter was running during this time – an additional 8-1/2 hours of time. There was a change fee involved as a pass-through item and a car rental to drive home. The ultimate insult was that the trip report for the visit was over 3 weeks late in being submitted. The question: what was the CRA doing for the near 6 hours of airport time and why could the report not be completed sooner?
If the forms had been electronic, and a checklist aligned to assist the visit conduct, we would have saved a tremendous amount of time and money. The coordinator also asked about receiving the materials electronically as they are capable of storing them in a file to be referenced during the trial.
For us, a lesson learned to utilize electronic forms – checklist, initiation visit materials, signature forms, and trip report documents would have enabled a smoother visit.