Some sponsors will reserve funds for small investigator-initiated studies, especially if they want to create good will at the site. Usually, these are conducted at large academic medical centers, with funding through grants, which are written by the investigators.

SoCRA developed the Certified Clinical Research Professional Certification program to evaluate a CRPs knowledge, understanding, and application of the conduct of clinical investigations involving humans in accordance with the International Conference on Harmonization Guideline for Good Clinical Practice (E6) (ICH/GCP), the United States Code of Federal Regulations (CFR), and the ethical principles that guide clinical research consistent with the principles of the Nuremberg Code, the Belmont Report, and the Declaration of Helsinki www.​socra.​org (Fig. 5.4).

In clinical research, SOPs help define the Practice’s Research Department or Research Site standard practices and internal processes conducted to assure execution of research studies in accordance with Federal and State Regulations.

SOPs should guide research staff through a particular procedure and provide uniformity in the daily functions of the research department. The SOP should be written in a generic format to allow for easy implementation across a broad set of various aspects of multispecialty trials, but yet should specifically define procedures that can be followed without deviation.

The SOP should include the objective of the SOP, definition of key terms and acronyms. SOP must reference applicable guidances and regulations within the SOP, such as ICH E6 Good Clinical Practice and 21 CFR 50. The SOP should include the signature of the Research Administrator or Director with the date of approval.

SOPs should be reviewed at regular intervals (preferably annually) to reassess applicability of the policy.

Research staff should be educated and trained on SOPs. I suggest documenting the date when research staff have been appropriately trained and agree to comply with SOPs. Your staff should be monitored to ensure compliance and receive refresher training at regular intervals.

The following topics should be covered in your SOPs:

Feasibility is assessed at several levels. It is defined as the process of determining whether a trial can be conducted at your location given the parameters provided to you by your sponsor. Feasibility is very important to your sponsor, because nearly a 1/3 of the delay of clinical trials is due to subject enrollment. About 1/5 of investigative sites don’t enroll any subjects and about 1/3 of sites enroll only 5 % of total subjects. For sponsors, only 1/3 of the sites reliably enroll volunteers. You want to make sure you are in that 1/3 category. If you are, you will be in good company, and you will be invited back for future studies.

Feasibility at the program level is defined as an entire program, for example inflammatory skin disease, or cutaneous oncology. By definition, the scope of program level feasibility is broad. You have to decide if such a program has a reasonable chance of success in your area. For example, you may have a clinic in a small college town. The majority of your patients may be students, and the other faculty and residents of the town may be small in number but relatively young. A cutaneous oncology program focusing on skin cancers of the elderly may not be suitable for your research enterprise.

Feasibility at the study level has to do with your assessment of whether a study is doable. You want to analyze it from a clinical standpoint to see whether it is reasonable, but you also want to see if the regulatory, technical, and operational hurdles of the study are easily surmounted. Ask yourself if the protocol has any requirements which depart significantly from what you consider to be an acceptable study and clinical practices. Ask yourself if the regulatory burdens of the study allow it to be approved in a reasonable time frame, or if you will require time and resources to evaluate the study and get the approval of others in your research group, or other regulatory or administrative body. The study should require readily accessible technical tools, or supply them. Make sure there are no operational challenges to your efforts. For example, if your research center is in a community with several academic institutions or research centers, make sure that nearby sites are not being considered or haven’t been selected. This could hurt the sponsor and would hurt you, because nearby sites would be competing for volunteers from the same recruitment pool.

You will likely have to sign a confidentiality letter before you can look at a protocol. When you are reviewing a protocol, it is important for you to determine if it is feasible for your site. It is preferable to opt out of a study which is not suitable for you than to accept one and be unable to complete it because of foreseeable obstacles. Your ability to conduct and complete studies will build your reputation and attract more studies and sponsors. If you are regularly unable to fulfill study obligations, you may dim your prospects as an investigator.

First make sure you don’t have any competing trials. You will duplicate your efforts and dilute your enrollment. Ask yourself if you’ve done similar studies, and whether they were successful. If so, this is a good sign that the current trial is suitable for your site. The enrollment criteria should be clear and should be suitable for your patient population. Sometimes inclusion criteria are unclear. For example, if a protocol for psoriasis requires patients to enroll who are not taking steroid medication, without specifying how much steroid medication, for how long, and by what route (oral, topical, inhaled), you may inadvertently exclude or enroll the wrong subjects. Think about other factors which may hinder subject enrollment. For example, are subjects too young or too old? Does the study last too long (years?)? Are study visits too frequent, and would they interfere with the subjects’ daily lives? Is the dosing of the medication too frequent, or impractical (for example, after applying topical study drug, subjects must wait an hour before washing or wearing makeup)? The washout period allows subjects who are taking prohibited medications to discontinue the medications for a set period before being eligible for a trial. For example, subjects in a trial for atopic dermatitis may be allowed to start the trial after avoiding all topical steroids or topical immunomodulators for 4 weeks. Are there too many prohibitions on concomitant medications? Is the washout period too long, or too strict? Are there any procedures which cause undue discomfort to patients?

When reading the protocol, it’s important to ask yourself if criteria are vague, or unclear, or too strict. You can jot notes in the margin and bring up your questions during a site qualification visit or during the investigators meeting. Sponsors welcome Site/Investigator feedback. They want you to succeed and they want the study to succeed. It suggests an attentive and interested investigator. Often, the protocol will be amended based on Investigators feedback. The appointment times for visits should be suitable for your schedule and subjects’ schedules. A study with rigid visit windows over the holiday season may have limited enrollment or a high drop-out rate. A year-long study which requires that the same investigator evaluate a subject at each visit without provisions for substitute sub-investigators or co-investigators may not be feasible, or require a special subject retention plan. A study medication which requires occlusion with adhesive tape may not be suitable for subjects in a hot humid locale in the summer. If you find an obstacle in the study, try to think of suggestions to overcome it. A study drug for actinic keratosis which excludes patients with a history of skin cancer of any type could potentially be modified to include patients with a nonmelanoma skin cancer which has been successfully treated. You also need to determine if the sponsor has adequate resources and personnel to support you in the trial. If the trial requires specimens be shipped to a central laboratory, clearly marked shipping containers should be made available. If a protocol requires biopsy specimens to be snap frozen in liquid nitrogen and shipped on dry ice to a central laboratory future genetic analysis, be sure you get details. Look in the protocol for step-by-step instructions on obtaining and preparing the specimen. Check that you are supplied with all the necessary materials and reagents, including biopsy kits, sutures if necessary, specimen vials which are stable to snap freezing, liquid nitrogen and personal protective equipment for its handling, dry ice, insulated mail containers, added cost for transporting specimens, and clearances for shipping human tissue. It’s not good to find out midway in the study that a particular supply item is an out-of-pocket cost to you, or that your shipping container is not labeled or suitable for human specimens (Fig. 5.5).

Determine if you need specialized equipment. If this is something that needs to be purchased, is it in the budget? If this is something that you can lease or borrow from colleagues or a third party, will you be reimbursed for your costs? Ask where the study is conducted. Determine if the care is provided exclusively in your office, or your study site, or the hospital. Find out if you can see subjects in all locations, or if only certain sites can be used for part or all of the study. This is particularly important if you are working with co-investigators at multiple locations. Your sponsor, or the trial may insist that only one physical site be permitted for subject assessments. You may still be interested in such a trial, but you may have to be sure that travel times to the site and patient evaluation windows do not conflict. Ask if any special personnel are required to conduct the study. For example, you may be doing a trial on a biologic agent such as a tumor necrosis factor inhibitor, which is known to have potential cardiac toxicity, and may be required to do an electrocardiogram which is read by a board-certified cardiologist. Or, you may be required to administer a study drug intravenously. This will require trained and qualified staff. Ask if you will need to see subjects outside of standard clinic hours. For example, in phase I trials, some pharmacokinetic measurements need to be done over a 24-h time frame. Be sure you have the capability to deal with this exigency. Determine if, in your clinical opinion, adverse events, particularly severe adverse events are to be expected, or likely. This will add to your cost and time. You will need to budget accordingly. Alternatively, you may not be able to participate in a study of a medication fraught with burdensome side effects.

You also want to vet your sponsor or SMO/CRO. You want to research your sponsor’s track record, particularly in dermatology studies. You want to make sure they are adequately funded and have qualified and responsive personnel. You want to see that their protocol is well-thought out and well-written. If you find too many gaps or have to make too many suggestions and amendments just to get the protocol off the ground, of if your comments are brushed aside or disregarded, you may need to reconsider your collaboration with this Sponsor. You also want to gauge the sponsor’s long-term health. If you are audited by the FDA 2 years or 10 years after the study is completed, will the sponsor still be around?

Administrative support: from your practice manager, or your hospital or institution. If your institution doesn’t support you, you’ll have a difficult task succeeding in the study.

Subject recruitment/retention: How will you recruit subjects? Will you be able to get enough? Are the enrollment criteria reasonable or too restrictive? Does the sponsor help with recruitment? How sick is the subject population (greater risk of AE, SAE). Are there known risks for a similar class of drugs? How interesting is the study to you, or to your subjects (Botox)? Will you be able to retain your subjects? What compensation do they get? Is it fair or coercive? What about medication at the end of the trial?

Compliance: is it too difficult, too uncomfortable, too tightly scheduled leading to high dropout rates? Will subjects have to miss school, work, vacation? Is dosing inconvenient, difficult, painful? Is there flexibility in the time schedule, or is it very rigid?

Personnel: do you have enough and do they have the right skills? If not, who will provide the training? How much time will training require, and will it take them away from other commitments? Do they understand their roles and responsibilities? Do they understand the ethics of clinical research? Do they understand confidentiality, HIPAA, FAA (Federal Aviation Administration) shipping regulations, OSHA regulations? Do they have the appropriate vaccinations and personal protective equipment?