Create tools to facilitate efficient documentation

Make your own site source documents

The site source documents sponsors send to clinical research sites often lack some important information the sites need in their efforts to comply with research rules and regulations. So a research organization in Memphis, TN, has created its own coordinator tools and source documents.

This improves its documentation and operational organization and allows for easier monitoring and auditing, says Derita Bran, RN, CCRC, manager of clinical trials operations at UT Medical Group Inc. of Memphis.

"We felt like we were good at doing what we needed to do," Bran notes. "But we felt it would help with organization if we created a site checklist to document compliance with all ICH GCPs [good clinical practices]."

For example, Bran created a site source document that lists all the ICH GCPs for informed consent. It has the principal investigator, coordinator, or co-investigator mark "yes" or "no" for 15 different steps. (See informed consent checklist box, below.)

Here are site source document sample IC items

Every step is documented

The UT Medical Group Inc. of Memphis, TN, creates source documentation checklists for site visits, screening visits, and other clinical research activities. Here are some sample items included on the template for a screening visit that includes an informed consent process:

  • All of the inclusion criteria have been met (Yes or No)
  • None of the exclusion criteria have been met (Yes or No)
  • The following person(s) were present for the informed consent process: (fill in the blank)
  • The consent form/study was explained by: (fill in the blank)
  • If the PI/sub/co-investigator was not present for the informed consent process, (fill in the blank) was available to answer questions
  • Dr. (name) is aware the subject was enrolled in the study on (date)

And it includes these yes and no checklist items:

  • The IC process was performed in a comfortable, quite, and private location
  • The subject and/or LAR was given ample time to read the consent form
  • Version (fill in blank) of the ICF was signed today before any study procedures were performed
  • The subject and/or LAR was offered the opportunity to take the ICF home to discuss with others; the ICF was taken home
  • The contents of the informed consent were discussed with the subject/LAR including the following nature of the study, randomization, risks/benefits, duration of participation, no penalty for not participating, side effects, procedures (designating which one(s) are for research purposes only)
  • The subject and/or LAR was encouraged to ask questions regarding the study; Questions asked by the subject/LAR (fill in the blank)
  • Methods other than discussion were utilized to explain the study; If so, list other methods (fill in the blank)
  • All questions were answered to the subject/LAR's satisfaction and understanding
  • Subject/ LAR voiced understanding
  • Subject/LAR voluntarily agrees to participate in the clinical trial
  • Subject verbalizes that he/she has read the informed consent form
  • ICF signed prior to any study related procedures being formed; Date/time ICF was signed (date/time)
  • Copy of the signed and dated ICF given to subject/LAR
  • Was a witness utilized during the process? If so, explain (fill in the blank)

The form also contains room for comments, date of next scheduled visit, and signatures with dates by study team member completing form and the principal investigator.

"Sponsors' site source documents do not always cover everything you need," she says. "They might not show the principal investigator's oversight or documentation of ICH GCPs."

While it's time-consuming creating these checklists and templates, they save staff time during studies because they make it easier for coordinators to complete documentation. Also, the templates can be used to more quickly put together site visit checklists for studies, she adds.

"Our informed consent checklist is okay for all studies, but for specific study visits we'll need to change these for each protocol," Bran says.

UT Medical Group's research staff loves the idea of the checklist because it saves them time and hassle when compared with the old process of handwriting documentation notes, she says.

"At the beginning of a study it takes time to set these up, but the more someone creates them the less time it takes," she explains. "Depending on the protocol, it might take 30 minutes to a couple of hours to create the site source documents for all of the study visits."

Here is how Bran and site coordinators create the site source documents for each study:

• Include all regulatory and other compliance standards: The first step is to create templates that incorporate all of the regulatory documentation and process steps needed in clinical trials, including following the Food and Drug Administration (FDA) regulations and the International Conference on Harmonisation (ICH) /World Health Organization (WHO) Good Clinical Practice standards. The ICH guidelines are standards for the United States, the European Union (EU), Japan, Australia, Canada, and the Nordic countries.

"The ICH GCP standards are more detailed than FDA regulations, and they give more specific directions of what to follow," Bran says.

The differences can be subtle, but important in documentation.

For example, the FDA regulations say that research sites should give the subject a copy of the informed consent form while the ICH GCPs say sites should give subjects a signed copy of the informed consent form, Bran explains.

Research coordinators can draw from guidelines when creating templates for the site source documents. One that might prove useful is the FDA's 2009 information sheet on principal investigator responsibilities. Other sources include the research institution's standard operating procedures (SOPs).

• Obtain input from research coordinators and anyone else who uses the documents: Bran started this process by speaking with coordinators about key information needed in site source documents.

Bran explained the reasons why a research site needs its own site source documents and cannot always rely on the sponsor's material. And she obtained buy-in and trained coordinators how to create their own site source documents for each study.

Coordinators can pull site source documents from other studies, copy and paste the information, and then tweak these to fit the new protocol, Bran says.

• Adapt templates to the sponsor's requirements: Each site visit source documentation checklist is adapted to the protocol's site visit information. But research coordinators also can adapt the document to other information requested by the sponsor.

"If the sponsor gives us a checklist or worksheet and they want us to use their checklist, then we use ours in addition to theirs," she says.

"I had a sponsor several years ago who I sent our site source documentation to make sure they were okay with it," she adds. "The sponsor ended up asking if they could use our site source documentation for all 50 of their sites."

It's more common now for sponsors to have their own checklists and worksheets, so these can have additional information to add to the site's own site source documentation material, Bran says.

• Keep checklist detailed and specific: It's important that every single step is noted in the site source document because even the smallest detail could prove important later in during an audit.

For example, in a women's health study, participants might be required to have a urine test and pap smear, Bran says.

"The protocol stated that you perform the urine test before the pap smear," she explains.

The worksheet/site source documents reflected that timing nuance: "We put down that the urine test was performed before the pap smear, and we included a checklist that showed compliance," Bran says.

"We could have written down the times that the pap smear and urine test were performed, but it was easier to put it in a worksheet or checklist, and it helps us as a guideline to know what steps to take for that visit," she adds.