This course is designed so that the participants walk away with usable skills and invaluable knowledge in clinical trial site visit report writing and review. The course combines lecture with real life scenarios, practicum exercises involving writing, editing and mapping of findings. Both beginners and those with experience will benefit from the content.
Locate and become familiar with industry regulations and guidelines relating to report writing
List the rules for writing an effective report
Identify the steps in effective report writing
List the essential content of the four major types of monitoring visit reports
Define the report mapping process relating to action item identification, documentation & resolution monitoring
Identify the difference between efficient and inefficient report writing tools
Demonstrate the ability to write a protocol deviation, onsite data query, action items, and more
Clinical Research Monitors
In-house and field CRAs, CRCs transitioning to CRA role
Anybody responsible for reviewing clinical reports including Project Managers, Quality Assurance Auditors, CRA Managers, Lead CRAs
The course will be led by one of the following instructors:
Nikki Christison, B.S.
Karen Gilbert, B.S., C.C.R.A.
Lily Romero, P.A., C.C.R.C.
Click here for complete trainer biographies
Day 1: 8:30 a.m. – 5:00 p.m.
- Report Writing Roots and Mandates: FDA requirements regarding monitoring, record and report keeping; ICH guidelines for monitoring visit reports and non-compliance
- 10 Rules of Effective Report Writing: Application of good report writing practices; steps in report writing: before, during, after
- Approaches to Report Writing: Objective vs. subjective, choice of tense & voice, use of abbreviations, fragments vs. full sentences, proper use of bullets, etc.
- Remember Who Your Audience Is: Who reviews and has access to monitoring reports
- Always Be Ready if Abducted by Aliens: Designing reports to be independent of author to smoothly handle staffing changes and/or temporary stand-ins
- The Mapping and Flow of Reports: Each report depends on one another; reports and follow-up letters correlation; contact reports; mapping to action item resolution
- The Major Types of Monitoring Reports: Evaluation, initiation, interim, closeout, combos and abbreviated
- Use of References to Support Report Claims: Documentation of protocol sections and past correspondence, etc.
- Answering the Question Right and Answering the Right Question: Comment when needed; make it mean something; document teaching and re-instruction; document what was accomplished and what was not
- Compliance Plans: Development, agreement, and success!
- Industry Standards: Best practice; goals and content of industry monitoring reports; regulatory authority use of report content
The Mapping Process: Documenting and Critiquing
Writing Critic: Review of “the Good, the Bad and the Ugly”— Documentation of findings, use of bullet points, documenting deviations from the protocol & other discrepancies, writing action items, writing on-site data queries, phone contact reports
Group Discussions of Best Practices
Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.
Special rates are available for multiple attendees from the same organization. Contact Elizabeth Andrews at 781-972-5418 to discuss your options and take advantage of the savings.
Click here for our seminar cancellation policy
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 7 hours (0.7 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE# 0778-0000-12-092-L01-P. Released: 8/12.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.