Study Start-Up

For research, source documents are defined as the first place information is recorded. If you plan to collect information that you normally would not, create forms specific to your protocol for capturing this. If you forget to capture protocol defined measures, you have deviated from your protocol which may be reportable, and you may not be able to prove your endpoints if you leave missing data.

Source documents should limit protected health information (PHI) as much as possible, but research staff should easily be able to match the source to the correct study patient for safety reasons. Case report forms should be de-identified (not contain any PHI). Consider using REDCap™ and a source or CRF. See the sample source document tools in resources.

Hospital policy requires that essential regulatory documents be maintained for all studies. See UH Research SOP SS 301: Maintenance of Research Regulatory Documents for help in organizing a regulatory binder and read GCP E6 R2 (Section 8) for details and purpose of the Essential Regulatory Documents.

Consider attending Education: Regulatory Binder and Essential Regulatory Documents and contact ClinicalResearch@UHhospitals.org for help.

Each time you start a new study, you should meet with your study team to have a protocol training team meeting. Require the attendance of everyone doing work on your study.

If you cannot come together in person then a web or teleconference is a good alternative. This is a great time for the primary investigator (PI) to delegate tasks and train everyone on what their responsibilities will be in a meaningful and transparent way.

Be sure to document this training for each staff’s training record and make available in the event of an audit. Also, be sure to have a plan in place for PI oversight of the entire study and for the study tasks that have been delegated to the study staff. Remember, the PI can delegate tasks but is ultimately responsible for the conduct of the study. All tasks must be delegated to a person who is qualified to do the task (clinical or non-clinical), see UH Research SOP GA 104: Scope of Practice.

During the team meeting and protocol training is a good time to complete the Study Staff Delegation log if you have not already.

As you add new research personnel or remove old, modify the log, the Institutional Review Board submission and training records accordingly. Also be sure that CITI and CREC certifications, CVs and licenses remain up-to-date and are available.

Some notes:

• Train all investigators and staff on the protocol prior to any study activities and retrain with changes to the study.
• All tasks that the PI delegates must be listed on the delegation log.
• Read the following Clinical Research SOPs:
  • GA-104: Scope of Practice
  • GA-105: Investigator Responsibility for Study Team Training and Documentation
  • SS-303: Site Initiation Visit

Once a fully executed agreement is in place, the Pre-Award Grants & Contracts Pre-Award team notifies Grants & Contracts, Post-Award Grants Accounting, the department administrator and PI that a fully executed agreement has been received. The department administrator or PI then complete two forms:

1. Chart of Accounts
2. Award Form

Both forms should be emailed to UHCRCGrantsAccounting@UHhospitals.org or to the GA assigned to your department. Once received, Post Award requests a Project number from finance, adds new sponsors to the system, and sets up your account.

Finally, Grants Accounting sends an email with the Notice of Award containing necessary account information to the department administrator and PI. The assigned PTAEO number will be used to make necessary charges to the award.

Once your study has been IRB-approved and a grant account has been set up for the financial management of your study, you are ready to enroll patients. If your study involves clinical patient care, a member of your study team will be responsible for adding that patient to your study coverage analysis and updating that coverage analysis each time research-related care is provided to that participant. Contact your Research Finance Specialist for more information. The following policies and Clinical Research SOPs will help:

• UH Policy & Procedure R-2 – Research Patient Billing
• SOP SS-302: UHLSF Outpatient Research Patient Charge Billing Process
• SOP SS-304: Investigational Drug Billing
• SOP SS-305: Investigational Device Billing
• SOP SS-314: Velos eResearch – Access and Data Entry Requirements

It is a requirement to register your study on ClinicalTrials.gov before you enroll your first subject and to report results. See Research SOP SC-401: Registration of Clinical Trials in ClinicalTrials.gov and Research SOP SC-406: Results Reporting of Clinical Trials in ClincialTrials.gov for details regarding the process.