Proven Strategies – How to Prepare for Protocols at Your Site [Q&A]

April 13th, 2015

By George F. O. Okoth Msc., Clinical Research, CCRC, Walter Reed Project (WRP)/KEMRI

Q: What empowerment best practices or techniques does your site do to ensure mutual alignment with sponsors/CROs?

A: We have experience with the following practices.

  1. Training the site before the sponsor site initiation visit/investigator meeting to ensure that all study staff have a clear picture of the protocol and that all the supplies needed are adequately ordered and procured.
  1. Creating source documents simulating CRFs and using them during the dry run to see if they will be useful and easy to use during the study. This helps to reduce redundancy, takes care of deficiencies within the CRF, creates clarity, and allows ample time for modification of the CRFs and source documents before the study is initiated.
  1. Doing a “wet run” in which a member of the staff volunteers to go through lab and equipment tests. This includes mock shipment for temperature sensitive investigational products/controls. This will help you know if your instruments/equipment are ready for the trial, validate processes, and give you time make any adjustment or replacements before the trial starts. It helps to gauge the level of staff comfort and expertise in dealing with the instruments/equipment. Mock shipment will help ensure that your shipper has maintained the cold chain, and that the integrity of the investigational product/controls is maintained. Being able to sort out logistic issues before you ship your investigational products will not only help the site, but also ensure that the sponsor does not incur additional cost due to broken cold chain and wasted investigational products.

Q: Does your site have any metrics on study deviations – both before you implemented this practice and afterwards?  This is such a terrific practice, but many sites feel there isn’t time to do this.

A: Yes, we do. Being an experienced site with a working quality control/assurance and regulatory affairs department, we reviewed all the previous studies that were done and came up with the common areas of deviations and challenges for all the departments/study team. This has been a powerful weapon considering that study teams in developing countries (emerging markets) are unique.

Even with the knowledge that every trial is unique, there are common mistakes that happen during the trial process that can pose a challenge to credible data collection and protection of study subjects across all studies. If the entire study team is prepared up-front and these trends are monitored and watched over internally – before and during conduct of the trial – then the site is most likely to have a better and complete view of the study, and be prepared to produce credible data while protecting the safety and welfare of participating research subjects.

Q: How have you made the compelling case to your staff that it’s important to invest up-front to get it right before you “practice the protocol on real patients”?

A: As a clinical research center that exists to do clinical research, we do this two ways.

  1. Making the study team understand the importance and impact of the trial to future patients, to the world, and to them – their individual role, contributions and responsibilities in making this happen, and then rewarding and celebrating every good performance and achievement.
  1. Outlining the consequences of unpreparedness and deviations, and the impact they have on future patients, the sponsor, and the site – to its credibility and possibility for future trials.

These will set the facets of clinical trials in motion, and every study team member will be working towards doing what is best for the trial from the preparation (pre-trial) process.

Q: How did your site go about implementing these proactive measures, and do you have recommendations for other sites on how to best implement these practices?

A: We implement this in three ways.

  1. Reviewing the study protocol together (by the site team) to see if it can be implemented. Look at the study requirements, inclusion/exclusion criteria, number of study subjects required, laboratory tests and assays to be done, any special tests/equipment needed and the site’s ability to do them or need to outsource/capacity build, SOPs and SSPs that need to be developed, and study budget versus the sponsor’s expectations and budget provisions.This will lead to the discussions being escalated to the CRO/sponsor before accepting the study. Once there is an agreement, then the ethical and regulatory submission process begins.
  1. Training of the study team on the study protocol. This involves thorough training on the ethics-approved protocol, informed consent forms, SOPs and study-specific procedures with a dry and wet run of the study. This includes continuous training on any amendments done during the study conduct.
  1. Holding daily meeting to review progress of the study and to plan for the following day (for the first week of the study conduct). The meetings are then graduated to weekly Monday morning meetings, where updates are given but with a caveat that there could be a study review meeting any time during the week as need arises. These meetings help in many ways, including handling any challenges that may be encountered, encouraging/motivating staff, giving study recruitment updates, and passing on any communications to the study team (upcoming monitoring visits, sponsor updates, review of procedures, etc.).

The above methods have worked for us, even when conducting more than two trials concurrently.

This post is part of the site empowerment campaign. To learn more about site empowerment techniques, you can find all of the articles here.

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