involving high-risk treatments (like cancer chemotherapy trials), a separate data safety monitoring

board or committee (DSMB or DSMC) should be arranged. A DSMB is typically required by the

sponsor, the investigator, the IRB, or a regulatory agency. A DSMB typically has about six members,

including expert clinicians in the relevant area of research and a statistician, who are external to the

study staff. A DSMB meets at regular intervals during the clinical trial to review the unblinded safety

data acquired up to that point. The committee is authorized to modify, suspend, or even terminate a

study if it has serious concerns about the safety of the participants.

Getting certified in human subjects protection

As you may have surmised from the preceding sections, clinical research involves regulatory

requirements that include penalties for noncompliance. Therefore, you shouldn’t try to guess how

to write a research protocol, obtain IRB approval, or engage in any other research methods with

which you are unfamiliar, and just hope that everything goes well. You should ensure that you,

along with any others who may be assisting you, are properly trained in matters relating to human

subjects protection.

Fortunately, such training is readily available. Most hospitals and medical centers provide training in

the form of online courses, workshops, lectures, and other resources. As you comply with ongoing IRB

training, you receive a certification in human subjects protection. Most IRBs and funding agencies

require proof of certification from study staff. If you don’t have access to that training at your

institution, you can get certified by taking an online tutorial offered by the NIH

(https://grants.nih.gov/policy/humansubjects/research/training-and-resources.htm).

Collecting and validating data

Data in a clinical trial are typically collected digitally and manually. Examples of data collected

digitally include a participant filling out an online survey or a blood pressure monitor collecting data

from a participant. Data are collected manually when they are written down on paper first, then

undergo data entry to become digital. Either way, some paper forms may be included, and many digital

forms are created for data entry in a clinical trial. These forms are for data entry of data collected from

various parts of the study, but in clinical trial lingo, they are all referred to as case report forms, or

CRFs.

In the case of digitally collected data, the central analytic team will run routines for validating the

data. They will communicate with study staff if they find errors and work them out.

In the case of manually collected data, data entry into a digital format will be required. Study staff

typically are expected to log into an online database with CRFs and do data entry from data

collected on paper.

The sponsor of the study will provide detailed data entry instructions and training to ensure high-

quality data collection and validation of the data collected in the study.

Analyzing Your Data

In the following sections, we describe some general situations that come up in all clinical research,