Study Start Up

IRB SUBMISSION

All IRB submissions are done electronically using the institutional IRB system or a Central IRB as allowed by the institution (such as WIRB, Quorum)

IRB submissions will not be approved without an approved budget from the Office of Sponsored Research (OSR) (sequence depends on institution)
The following documents are included in the with the IRB submission:
- Protocol
- Budget (Department/Institutional requirements)
- Investigator’s Brochure
- Recruitment Materials
- Informed Consent
- Research Supplemental Submission (if applicable)

THE IRB: WHAT YOU NEED TO KNOW

You must complete CITI training prior to being added to a protocol
You must be added to a protocol with the IRB prior to obtaining patient consent or doing any protocol related tasks
You must have documented training on each protocol
No study procedures can be completed prior to obtaining informed consent
Unanticipated Problems: If you encounter a serious event that meets the following criteria, work with your PI to report the SAE to the IRB:
- Unexpected
- Related or possibly related
- Suggests the research places subjects or others at risk of unknown harm

RESEARCH RESPONSIBILITIES

Contract: Contracts analyst OSR, Coordinator, Investigator, Sponsor
Budget: OSR, Coordinator &/or Regulatory specialist
Informed Consent: Coordinator &/or Regulatory specialist
Regulatory: Coordinator &/or Regulatory specialist
IRB Submission: Coordinator &/or Regulatory specialist

CRITICAL REGULATORY DOCUMENTS

CDA executed
1572
CVs for all research staff involved in the study (signed and dated within 2 years)
Medical Licenses
Protocol
Amendments
Investigator’s Brochure

Protocol Signature Pages
Critical Correspondence
Test Article Records and Drug Accountability
Delegation of Responsibility Log
IND Safety Reports
Laboratory Certifications
Laboratory Reference Ranges

Lab Director’s CV and License
Telephone Logs
Site Signature Logs
Monitoring Log
Financial Disclosures
Conflicts of Interest
Enrollment & screening logs

Investigator’s Meeting: Prior to study recruitment many sponsors hold IM to train, cover AE and SAE reporting, lab procedures, certify investigators and/or staff in assessments and provide a background on the sponsor and protocol. These may be in person meetings or via Webinar or combined with the Site Initiation Visit (SIV).

Site Initiation Visit (SIV): Following the IM and prior to study start-up, sponsors will hold the SIV to train, cover AE and SAE reporting, lab procedures, certify investigators and/or staff in assessments, collect regulatory documents, verify the Delegation of Authority log and answer questions all site personnel may have about the conduct of the study.

SCREENING & ENROLLMENT

The protocol will specify when a subject is considered enrolled in a study.

Screening and enrollment logs to be maintained and provided to sponsor per protocol.
- Separate enrollment log with complete subject identification is necessary, to be filed in regulatory binder but not released to sponsor as it includes subject PHI.
Signature on informed consent before any study related procedures are completed.
Randomization per protocol
Treatment dispensed per protocol (if a treatment trial)

Questions to Ask when deciding whether to volunteer for research

CONSENT PROCESS DOCUMENT

It is critical to document the consent process for your site.

Some sites include in subject EDC chart or have a separate consent process document including that the subject has had time to review the ICF, all questions were answered and the subject received a copy of the signed consent document for their records.

Example of a Consent Process Document

Required Elements of Informed consent

Information must be provided to the subject in a language and level understandable to the subject (7th grade level)
Introduction
Study involves research
Purpose of research
Duration of subject involvement in the study
Description of study procedures
Identification of any experimental procedures
Potential risks/ discomforts
Potential benefits to subjects or others

Alternative procedures or treatments (that are already available to the potential subject)
Confidentiality of subject records (e.g. access to sponsor, FDA)
Compensation for injury and treatment in event of emergency
Who subject can contact
Participation is voluntary
New-March 7, 2012: “A description of this clinical trial will be available on https://www.clinicaltrials.gov/ , as required by U.S. Law. This web site will not include information that can identify you. At most, the web site will include a summary of the results. You can search this web site at any time.”

Unforeseen risks statement
Reasons for involuntary termination
Additional costs to subject
Consequences of decision to withdraw (e.g. impact on their health, treatment, personal welfare etc.)
New findings will be communicated
Approximate number of subjects in the study
Payments to the subject are to be included in the document and when they will be paid (e.g. incentive, travel costs etc.)*

ROUTINE MONITORING VISITS

Based on CRO/sponsor requirements study monitors will be asked to come to the site generally within 2 weeks of initial enrollment then every 4-6 weeks. These requirements vary from sponsor to sponsor, may be impacted by enrollment numbers and phase of study.
Frequency of visits may decrease in the open extension phases of study.

RESEARCH DRUG/INVESTIGATIONAL PRODUCT

Drug storage: Investigational drugs will be stored in the appropriately secured location (i.e. refrigerated or frozen compounds). Accurate and complete drug accountability records MUST be maintained.
- Investigational drugs, which are dispensed to patients, shall be dispensed only by authorized personnel (under the supervision of the study physician or registered nurse) and in accordance with all state and federal, and institutional regulations as required by law.

Investigational Drug Disposal: Investigational drugs shall be returned or destroyed according to the protocol and drug company policy. If destroyed on site follow your institutional or facility policies for hazardous waste.

Temperature logs: All logs for drug cabinets, refrigerator and freezer must be maintained and available for review by the sponsor or designees. Some sites use and institutional research pharmacy and the logs are maintained there.

Study Drug Blind Envelopes: In a separate binder, appropriate personnel have access to the blind envelopes for all studies. These blind envelopes are maintained until retrieval by study monitor at closeout. Sometimes these blinds are on the I/P container itself rather than a separate folder. They are however, available to designated study personnel in the event of an emergency. Every effort is made to keep the studies blinded and the sponsor is notified before the blind is broken.

RESEARCH SOP’S

It is important to develop site-specific Research SOP’s.

Include record retention policies, location of offsite storage if applicable, drug destruction policies and plan, specific location of temperature logs and archives of these, maintenance of equipment logs (annual recalibration)
Outline site-specific responsibilities for research requirements
Disaster Plan if one is applicable

ACCESS FOR MONITORS

Access for monitors to patient electronic records may be based on institutional requirements. Some will have certified copies of the patient records printed and dated and provided by the coordinator. Other sites may actually allow sponsor designees “read-only” access to patient records.

Submit requests 2-3 weeks in advance
- Monitor full legal name
- Date of Birth
- Last four digits of Social Security Number
- IRB approval letter
- Department
- Start date for access
EPIC: 1 year (varies by institution)
Powerchart: 90 days
- Signed Confidentiality Agreement