Study Start-Up

1. Source Documents and Tools

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.

2. Regulatory Binder

University Hospitals 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 Guidelines (section 8) for details and purpose of the Essential Regulatory Documents.

Consider attending Education: Regulatory Binder and Essential Regulatory Documents and contact for help.

3. Site Initiation

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 certification, 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: SOPs GA 104: Scope of Practice and SS 303: Site Initiation Visit. Read SOP GA 105: Investigator Responsibility for Study Team Training.
4. Grant Account Set-Up and Management

Once a fully executed agreement is in place, the Grants & Contracts: Pre-Award team notifies Grants & Contracts: Post Award, 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 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, Post Award 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.

5. Research Billing

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 SOPs will help:

  • R2- Patient Billing Under Research Grants
  • SOP SS 302: UHLSF Outpatient Research Patient Charge Billing Process
  • SS 304: Investigational Drug Billing
  • SS 305: Investigational Device Billing
  • SS 306: Investigational Pharmacy Fee Waiver
6. Clinicaltrials.gov

It is a requirement to register your study on clinicaltrials.gov before you enroll your first subject and to report results. See Research SOP SC401: Registration of Clinical Trials in ClinicalTrials.gov and Research SOP SC 406: Results Reporting in ClincialTrials.gov for details regarding the process.