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If you’re new to clinical research, or even if you’re not, sooner or later you’ll be tasked with authoring a clinical study report.

These reports are required by regulatory agencies here in the US and globally. They follow standards and guidelines set by an international group to facilitate creating a standard accepted by agencies in multiple countries.

“A clinical study report (or CSR for short),” explains Eli Lilly in a blog post, “Describes the endpoints or outcomes being researched, provides details on how the data were collected and analyzed, and confirms whether the study endpoints were met or outcomes were achieved. They help regulatory agencies determine if a potential new medication is safe and effective.”

The first questions a novice report writer may have, therefore, are “What do I include in the report,” “What’s the report structure,” “How do I write the report”?

The International Conference On Harmonisation answers those questions in a 49 page guideline that spells out the details and includes sample forms.

Even with the guidelines, preparing a study report is complicated work, requiring the collection of data, analysis and making sure it is both accurate and complete.

Fortunately, the Association of Clinical Research Professionals recently published a much less intimidating primer answering those questions and many more. “Clinical Study Reports 101: Tips and Tricks for the Novice” provides an overview of the CSR, giving us a framework for writing and organizing a report.

The author, Sheryl Stewart, goes into just enough background to give a first time author or contributor an understanding of what needs to be in these reports and why. That goes a long way to helping us know what a report must include. She helpfully points to templates, and reassures us that “there are no requirements to follow the template precisely. Not every section is appropriate for every study.”

Her top level discussion tells us the first step is to review the templates she recommends to help you organize the report. Outlining it will tell you what documents and data you’ll need.

The next step is to identify all the stakeholders. These will certainly include the clinical study management team, those tasked with responsibility for the data and others. In a “Tips and Tricks” section Stewart suggests, “Drafting a project charter or scope document to ensure commitment from all required teammates on scope, deliverables, and timelines.”

Each of the stakeholders should be given a time table for their deliverables. “Time management is paramount for clinical trial submissions to regulatory authorities,” Stewart says.

In her section on the writing of the CSR, Stewart briefly discusses each of the six sections, offering insights into the process. Write the executive summary last, she suggests, because it will be easier then.

She also has a few tips about the review process. Have the reviewers initially focus on content. Formatting and grammar errors are much less important at this stage. She also says that once the review team has signed off on a section, discourage backtracking unless something major changes.

How long should you expect the process to take? Experienced writers surveyed at medical writing conferences came up with an average of 17 days from delivery of the final tables, listings, and figures to first draft. And 26 days from first draft to the final draft sent out for review.

Photo by Scott Graham on Unsplash

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Far from becoming an employer market, hiring home health care workers is as hard as ever, industry executives say.

In September, Home Health Care News said industry jobs posted on Indeed were trending down, suggesting “home health and home care agencies simply aren’t looking to fill as many positions.” With the national unemployment rate at 8.4% in August and fewer jobs to fill, agencies would have an easier time recruiting.

Even then, some agency leaders felt differently.

“I think we have to respectfully disagree with that point, because it is challenging for us to find caregivers — and very challenging for us also finding the right one,” Ryan Iwamoto, the president and co-founder of 24 Hour Home Care, said in September. “That has been probably the biggest challenge that we’ve had.”

Now, an October survey by myCNAjobs found 57% of 281 participating home health care agencies admitting they are struggling with recruiting staff. Only 5% maintain they are doing well.

Despite a still high unemployment rate, hiring workers has become so much a challenge that 71% of the agencies report turning down business because they didn’t have the staff.

One important reason for the recruiting difficulty, according to 87% of the agencies, is COVID. 72% said the pandemic has also made retention and scheduling more difficult.

Just getting people to apply for a job is difficult. Almost 3 in 10 agencies say they get too few applicants; 23% say they can’t get applicants to call them back. And 35% say when an interview is scheduled, the candidates simply don’t show up.

That’s lead the industry to try bold new recruiting methods and experiment with flexibility in requirements and scheduling for their workers.

“COVID will reshape the labor market in many industries for quite some time,” said Brandi Kurtyka, the CEO of myCNAjobs, speaking at the online conference of the Home Care Association of America last month.

That’s already the case at Alternate Solutions Health Network, one of the largest operators in the country.

Amy Smith, corporate VP of revenue cycles, told Home Health Care News that Alternate Solutions courts restaurant workers. After bringing several on staff, the company discovered their experience in the busy, customer-focused food service environment taught them how to multitask effectively.

Instead of leaning toward candidates with health care experience, the company now looks more for candidates able to multitask, undaunted by the need to “start, pause, start something else, pause, and go back to something that was started weeks ago.”

Photo by Zach Vessels on Unsplash

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