How do you manage a research project?

Seven Essential Tips for Managing a Large Research ProjectIdentify your research question. Your research question is the core of your work. Master the literature. You can’t define your research question before you have a good grasp of the literature. Learn planning skills. Identify your checkpoints. Use technology to your advantage. Take notes. Work with students.

How do you destroy data?

When it comes to selecting ways to destroy data, organizations have a short menu. There are basically three options: overwriting, which is covering up old data with information; degaussing, which erases the magnetic field of the storage media; and physical destruction, which employs techniques such as disk shredding.

How long should I keep my research data?

The length of time you store data depends on the nature of the research project and the resultant data. Where it is workable, you should store all data (for at least the term of the project). Most researchers will store data for at least five years after final publication.

How long do you have to keep grant records?

Generally, you must keep all required records and supporting documents for a period of six years from the end of the last tax year they relate to.

How long do you have to keep clinical research records?

15 years

What are the 3 main GCP principles?

Three basic ethical principles of equal importance, namely respect for persons, beneficence, and justice, permeate all other GCP principles.

How long must you retain a Hipaa authorization for research?

6 years

At which study visits can the site expect the sponsor?

At which study visits can the site expect the sponsor to review subjects’ signed informed consent forms? Periodic and termination site visits. The subject informed consent forms are reviewed at the periodic site visits and the termination site visit.

What is a site selection visit?

Site Qualification Visit (SQV): A meeting with a representative from a sponsor representative to ensure the institution is fully capable and equipped to run a specific clinical trial. This visit may also be referred to as Site Selection Visit (SSV) or Pre-Study Qualification Visit (PSQV).

What is a protocol violation?

Protocol violations are any unapproved changes, deviations or departures from the study design or procedures of a research project that are under the investigator’s control and that have not been reviewed and approved by the IRB.

How do I prepare for a monitoring visit?

Preparing for a periodic monitoring visit:Identify a quiet place for the monitor to work and ensure access to a copy machine, phone, water fountain, and restroom.Complete all necessary CRFs.Confirm that Serious Adverse Event (SAE) forms have been submitted and are available for review.

What happens at a site initiation visit?

The Site Initiation Visit (SIV) prepares the research site to conduct the research study. The PI will personally conduct or supervise the clinical research study to ensure that the investigation is conducted according to the signed investigator statement, the investigational plan, GCP, and applicable regulations.

How do you write a monitoring visit report?

5 Guidelines for Writing a Useful Clinical Monitoring ReportDo Your Homework Before the Site Visit. To ensure all the information will be available to write the report, you should be thoroughly prepared for the site visit. Take Good Notes During the Visit. Write the Report as Soon as Possible. Check Reports Carefully. Be Sure the Report Only Includes Essential Information.