Expert provides list of basic SOPs for CT sites
Expert provides list of basic SOPs for CT sites
Put SOPs in place early-on
Clinical trial (CT) sites should have a basic list of standard operating procedures (SOPs) written and in place before research is initiated, an expert suggests.
"It is always best to have many SOPs in place before starting your program," suggests Cindy Mendenhall, CCTA, clinical research coordinator at Evergreen Healthcare in Kirkland, WA.
"That way if anything arises you can say, 'This is the way we have to handle this situation it's in our SOPs," she says.
Here is Mendenhall's list of suggested SOPs for CT sites:
- Contract and budget negotiations
- Site selection visits
- Site initiation visits
- Interim monitor visits
- Informed consent process
- Selection of IRB
- Procedure for assignment of central IRB
- Communication with the IRB
- IRB audits
- Adverse event reporting (in-house and IRB)
- Serious adverse event reporting (in-house and IRB)
- FDA audits (include how to respond to infractions, as well as how to conduct the audit from the site's perspective)
- Procedure for obtaining confidentiality agreements
- Study feasibility questionnaire completion
- Release of patient information to third parties
- Recruitment and retention (include pre-screening, pre-approval of media materials, internet advertising, and approaching another physicians' patient)
- Communication with subjects (email, postal mail, telephone calls, etc.)
- Privacy and protection of health information
- Drug accountability
- Storing investigational product (before, during, and after the study)
- Temperature logs
- Dispensing investigational product
- Lab processes (include, IATA certification, will you require or does your state require a phlebotomy license, disposal of hazardous waste, courier methods, etc.)
- Medical records search (include electronic, paper, and obtaining information from other facilities)
- Source documentation
- Protocol violations
- CRF completion
- Research training (when do you re-train staff on SOPs, new FDA regulations, protocols, amendments, etc.)
- Archiving and storing a study after it is closed.
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