Random audits put the prepare in preparation

Create SOPs for your SOPs

Preparation is key to improving a human subjects protection program, and this could include attending to details, such as creating standard operating procedures (SOPs) for making new SOPs, one IRB director has found.

When the research protection office at Baystate Health of Springfield, MA, began to prepare for the day it would seek accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP), the first step was to hire an integrity and education specialist and begin an auditing mechanism, says Karen Christianson, RN, BSN, CCRP, director of the human research protection program at Baystate Health. Baystate Health received full accreditation in June, 2010.

"Accreditation was a desired conclusion once we had everything in place," she says. "We began the process of auditing both investigators and the IRBs to take a look at where we stood in regards to standards."

The intent was to conduct both for-cause and not-for-cause audits, but Christianson quickly discovered that one auditor could not handle both.

"The random audits were not occurring with the frequency we wanted them to occur," Christianson says. "There always were things that came up and needed to be dealt with on a day-to-day basis."

The organization put in place policies and procedures for reviewing different types of research, as well as new SOPs.

"We rewrote the entire SOPs manual, and put it all in an electronic system," Christianson says. "We took an approach of ripping off the Band-Aid, instead of doing it piecemeal."

Then about a year ago, Baystate Health decided to audit each department with the goal of randomly sampling studies within each department and helping department leaders develop and implement well-written departmental SOPs, based on SOP templates created by the research protection office, she says.

"We developed education specific to that department's needs based on what we found through auditing," Christianson says. "We've been through four of the clinical departments and have five more to go, and that's where we're focused our energy right now."

IC varies by department

The audits helped the research protection office identify and help departments correct mistakes. Most of the problems identified in the departmental audits were misunderstandings of definitions or investigators taking research beyond the scope of IRB approval, but not in a way that impacts risk, she explains.

Also, the audits resulted in SOPs that were customized by each department.

"One department's approach to informed consent may be different from another department's approach," Christianson notes.

Departments send their SOPs to the research protection office for approval after they've made their changes.

The SOP templates are thorough and address a variety of research activities, including these examples: templates on the principal of documentation and case report forms to the consent process and documentation to an SOP on preparing SOPs.

The templates often are one-page long with five main subject heads, including the template's subject, policy, scope, responsibility, and procedure.

For example, the SOP on creating SOPs lists as its policy: "Baystate Health (department name) is committed to complying with research related to FDA, OHRP, GCP, and state regulations. It is the policy of the (department name) to follow these procedures when developing or amending policies and procedures. This policy describes the preparation and maintenance of the written procedures followed to ensure compliance for research studies conducted in the (department name). This policy also describes procedures for training on policies and documentation of training."

The SOPs template's scope is stated simply as the following: "This policy and procedure applies to the written policies, procedures followed by this research program as it participates in sponsored and investigator initiated research studies."

Under the section for procedure, the SOP lists the following: "Procedure for preparing new SOPs or revising previously issued SOPs:

(Name) or delegate based upon changes to the FDA regulations, guidelines, or research practice, shall write a new policy or revise a previously issued policy that describes the new or revised policy and procedure.

(Name) shall advise (department head) research staff conducting research-related activities of newly learned regulations and guidelines as they become available.

Each SOP includes the following in the header:

Department head

Policy Title

Policy number.

Quality control, archiving

"The SOP on principles of documentation includes mechanisms in place for quality control, query resolution, and archiving," Christianson says. "The SOP walks them through ways to approach documentation that are compliant with regulations and guidance."

Researchers conducting investigator-initiated studies particularly have need for this SOP because they don't have an external body looking over their shoulders, she adds.

Auditors might visit a department and find that all of the sponsored research has detailed and compliant documentation, but the investigator-initiated research is disorganized and lacking in necessary details, she says.

"So if the investigator-initiated studies were audited, we might find they don't have the documentation that's needed," she adds. "Our goal is to get them audit ready."

The audit readiness applies to governmental audits, as well.

For instance, Christianson recommends departments anticipate the issues the Food & Drug Administration (FDA) might address and apply to all SOPs and documentation the acronym ALCOA, which stands for attributable, legible, contemporaneous, original, and accurate.

"So far the weaknesses we've identified are in two areas," she notes. "The first is in documentation for investigator-initiated research, and that's where ALCOA really comes in, and the second is in documentation of the informed consent process."

When departments learn of the internal audit findings, they typically have one point person or a team of people work with the human research protection office staff to go through the audit's findings and the SOP process.

"We have a conversation with the department about everything that is put in place and why, and we provide targeted education," Christianson says.

"If the department is in a good place to start with, and it just needs tweaking to bring it where it needs to be, then we'll communicate that message and document what they've done," she adds.

The final step once new or revised SOPs are approved is to keep these documents alive through period review, Christianson says.

"Once we get them in place, we'll follow up on them," she says.

"Departments like having the structure in place," she notes. "If someone has a question on how long to retain a particular document, then this person can pull up the SOP and not just rely on his or her own memory."