Deliverables, Handover and Common Mistakes

Part of Clinical Research Associate (CRA) Training: Evaluating and Qualifying a Site.

About 5 minutes. Free, in your language, no account needed.

Why this matters

A pre-study visit that produces no usable document was a trip, not an evaluation. The deliverables are the work product, and they outlive you: they go into the trial master file and they are what an inspector reads years later.

What you produce

The pre-study visit report, sometimes called a site qualification report. A standardized document summarizing what was reviewed, what was found, the site's strengths, the risks identified, and your recommendation. This becomes part of the trial master file, so write it for a reader who was not there.

Feasibility validation notes. What the site claimed, what you checked, what you found, and what you asked for.

The site risk assessment or scorecard. The structured comparison across categories.

The recommendation. Select, conditionally select, or do not select, with the reasoning.

The outstanding items list. For conditionally selected sites: each action, its owner, its due date, and how it will be verified.

Write these promptly. A report written three weeks later loses the detail that made the visit worth doing.

The tools you will use

• Feasibility questionnaire — initial filtering of candidates.
• Pre-study visit checklist — ensures you cover facilities, procedures, storage, documents, calibration and staffing consistently.
• Site risk assessment form — the scorecard.
• Regulatory document checklist — what must be collected before activation.
• Training log — who has been trained on what.
• Start-up tracker — ethics submissions, regulatory packet, contract progress, activation milestones.

Sponsors supply their own versions. Use theirs. A CRA who prefers a personal spreadsheet creates a record nobody else can find.

From selection to activation

Once a site is selected, the CRA supports the steps that lead to activation. Module 5 covers contracts and Module 6 the regulatory documents; this is the sequence.

1. Complete the regulatory document package.
2. Confirm investigator, sub-investigator and coordinator training.
3. Verify facility and equipment readiness, including the conditions from your report.
4. Coordinate with the contracts and budget teams.
5. Support the site's ethics committee submission.
6. Begin building the site-specific monitoring plan.
7. Complete the site initiation visit.
8. Confirm activation in writing before any enrollment.

Track every dependency. Activation usually waits on the slowest of ethics approval, contract execution and document collection, and you should always know which one it is.

Handover

Sites often change hands between the CRA who evaluated them and the CRA who monitors them. A good handover transfers three things.

• The record: report, validation notes, risk assessment, outstanding items.
• The judgment: what worried you, what you would watch, what you were told informally.
• The relationships: who at the site actually gets things done.

Write the second one down. It usually exists only in the departing CRA's head, and it is the most valuable part.

The mistakes CRAs actually make

• Trusting feasibility answers without validating them. The most common error and the most expensive.
• Overlooking staffing workload. Assessing whether the site has the people rather than whether the people have the hours.
• Failing to assess investigator engagement, because asking feels impolite.
• Not verifying equipment calibration, which is a two-minute check that regularly finds something.
• Underestimating competing trials.
• Writing subjective or unsupported recommendations. "Great site, lovely team" is not evidence.
• Recording risks without mitigations, which tells the sponsor there is a problem and nothing about what to do.
• Writing the report late, after the detail has faded.
• Assessing the site rather than the site against this protocol. A site that is excellent for a simple study may be wrong for one requiring six-hour visits.

In practice

Leah's pre-study visit report for a VT-301 site conditionally recommends selection with two outstanding items: a monitored fridge alarm with out-of-hours escalation, and a named trained backup coordinator.

She writes the report the same week, with the specific evidence for each item and a due date before activation.

Four months later Leah moves to another study. She hands the site to a colleague, Daniel, with the file and a short handover note that says something the file does not: the site's regulatory work is done by a part-time administrator who is excellent but who works only on Tuesdays and Thursdays, so anything needed urgently on a Monday will not happen.

Six months after that, a regulatory inspection reviews the site's start-up. The inspector reads the pre-study visit report, sees the two conditions, and finds the evidence that both were met before the first participant was enrolled.

Daniel, meanwhile, has never once scheduled an urgent regulatory request for a Monday.

Write the report for the inspector. Write the handover for the next CRA.

Key takeaways

• The deliverables are the work product: the pre-study visit report, validation notes, risk assessment, recommendation, and an outstanding items list with owners and dates.
• The pre-study visit report enters the trial master file, so it must be written for a reader who was not there and who may read it years later.
• Use the sponsor's own tools and templates, because a personal spreadsheet creates a record nobody else can find.
• A good handover transfers the record, the judgment and the relationships, and the judgment is the part that usually exists only in the departing CRA's head.
• The commonest mistakes are unvalidated feasibility answers, unassessed workload and investigator engagement, unverified calibration, and recommendations without evidence or mitigations.