Your SlideShare is downloading. ×
Microsoft Word - SOP-Recruitment of Participants - Research Unit.doc
Upcoming SlideShare
Loading in...5
×

Thanks for flagging this SlideShare!

Oops! An error has occurred.

×

Saving this for later?

Get the SlideShare app to save on your phone or tablet. Read anywhere, anytime - even offline.

Text the download link to your phone

Standard text messaging rates apply

Microsoft Word - SOP-Recruitment of Participants - Research Unit.doc

466
views

Published on


0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total Views
466
On Slideshare
0
From Embeds
0
Number of Embeds
0
Actions
Shares
0
Downloads
6
Comments
0
Likes
0
Embeds 0
No embeds

Report content
Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
No notes for slide

Transcript

  • 1. TEMPLATE FOR CLINICAL RESEARCH To be used as a guideline only Standard Operating Procedure Number: 1-5 Recruitment of Participants for Clinical Trials Adopted: 02/2005 Revised: Page 1 of 6 RECRUITMENT OF PARTICIPANTS FOR CLINICAL TRIALS PURPOSE AND SCOPE This SOP describes the procedures study personnel will use in meeting study enrollment goals while fulfilling ethical responsibilities for protecting the rights and welfare of participants. APPLICABLE REGULATIONS AND UC POLICIES Policy II.04 Reviewing Recruitment Materials in Human Subjects Research PERSONS RESPONSIBLE Principal Investigator. The Principal Investigator is responsible and accountable for: 1. Getting IRB approval of the methods to be used to recruit participants, including review and approval of recruiting materials. 2. Assuring that all participants understand that the purpose of the study, its risks and benefits, and the alternatives to the research. 3. Assuring that all participants meet inclusion/exclusion criteria. 4. Assuring that all participants have given informed consent prior to study procedures being performed. 5. Reporting accurately to the IRB for continuing review 6. Maintaining accurate and complete records of potential and enrolled study participants. The PI may delegate responsibility for recruiting and enrolling participants to other qualified researchers involved in the study, but may not delegate accountability. Clinical Research Coordinator/Clinical Research Nurse will be responsible for: 1. Monitoring the progress in recruiting patients.
  • 2. TEMPLATE FOR CLINICAL RESEARCH To be used as a guideline only Standard Operating Procedure Number: 1-5 Recruitment of Participants for Clinical Trials Adopted: 02/2005 Revised: Page 2 of 6 2. Keeping records of subject recruitment. 3. Informing the PI about progress toward recruitment goals. 4. Reviewing each participant’s information/history for inclusion/exclusion criteria verification. PROCEDURES Recruitment strategies 1. Participants can be recruited from a variety of sources including clinician referrals, internet postings, newspaper advertisements, television/radio advertisements, from support groups, health fairs, or from local hospitals and clinics. Clinicians can be notified about research studies by letter or by word of mouth. 2. Many researchers maintain a database of patients or former research participants from which they identify potential participants for new research. If potential participants are identified through the researcher’s database, researchers must present a HIPAA waiver of authorization prior to accessing the database in order to contact potential participants. If IRB approved, research staff can access this database and make phone or letter contact with past subjects who may meet entry criteria. This activity will be overseen, by the Recruiting Manager and Clinical Study Manager who will coordinate study contacts. 3. Researchers who get referrals from physician colleagues may not contact these referrals directly. The physician colleagues of the researcher may inform their patients of the research and encourage their patients to contact the researcher. 4. Researchers may identify potential participants for research from hospital medical records by getting an approved waiver of authorization from the IRB/ Privacy Board. 5. Financial or other incentives provided to research staff by sponsors based on numbers of participants recruiting or enrolled are strictly prohibited. Recruitment Materials 1. Materials directed to patients or the general public with the intent of recruiting them to participate in clinical research must be submitted to the IRB for review and approval. These include announcements, advertisements, flyers, phone scripts for screening, oral scripts for consenting participants, newspaper ads, videos, radio and television announcements, bulletin board tear-offs, Internet postings, and posters.
  • 3. TEMPLATE FOR CLINICAL RESEARCH To be used as a guideline only Standard Operating Procedure Number: 1-5 Recruitment of Participants for Clinical Trials Adopted: 02/2005 Revised: Page 3 of 6 2. Materials that do not require IRB review include letters to physicians describing the research, medical society newsletters, news stories and public service announcements, publicity intended for audiences other than participants (such as financial page advertisements directed towards prospective investors), listing of studies where only the title of the study, the investigator, and contact information is listed. 3. In sponsored research, the sponsor must also approve all recruitment materials. 4. Advertisements may include: • A statement that the study involves research • A brief description of the disorder that the study is investigating • Eligibility criteria (in summary form) • A truthful description of potential benefits, if any, to the subject from study participation • The name of the institution conducting the study • The name and phone number of person to be contacted for further information 5. Advertisements may not include: • Any direct or implied claim that the purpose of the research is to treat the condition or that the study medication is safe or effective • Any expressed or implied claim that the research will improve the subject’s medical condition • Expressed or implied statement that the research is FDA-approved • Use of the term “new” unless modified, i.e. new research medication, or new investigational medication 6. If potential participants who respond to advertisements will be queried to determine whether they meet inclusion/exclusion criteria, the telephone script used by researchers must also be reviewed and approved by the IRB. Any questions about criteria should be referred to the PI. All such contacts/discussions must be recorded. 7. In addition to submitting recruitment materials to the IRB, the PI must describe in the protocol the way in which the materials will be used and any other methods that will be used to recruit participants to the study. Enrollment Procedures 1. Recruitment rates should be regularly evaluated during the recruitment period, with reassessment of the strategy when recruitment targets are not being met. When there is
  • 4. TEMPLATE FOR CLINICAL RESEARCH To be used as a guideline only Standard Operating Procedure Number: 1-5 Recruitment of Participants for Clinical Trials Adopted: 02/2005 Revised: Page 4 of 6 competitive enrollment, recruitment must be continually reassessed to manage screening of participants. 2. The Clinical Research Coordinator/Nurse will keep records of recruitment and will inform the Principal Investigator and the monitor of progress in recruiting patients. Every person who is considered a potential candidate for the study should be entered in the Screening and Enrollment Log (based on study inclusion and exclusion criteria). Note whether individuals have enrolled in the study and, if not, document the reason. 3. At the screening visit, the potential participant must give informed consent prior to any screening procedures. Signed informed consent forms from subjects who terminated their participation in the study during the screening process should be retained. 4. After screening and/or randomization, the participant’s code/ID number should be entered in the Screening and Enrollment Log. The Enrollment Log can serve as the coded subject list, which must be archived at the end of the study. If there is no Screening and Enrollment Log included in the study, a master log must be kept of all subjects randomized in the trial, with subject name, address, year of birth, and treatment allocation or treatment package number. ATTACHMENTS Screening Enrollment Log
  • 5. TEMPLATE FOR CLINICAL RESEARCH To be used as a guideline only Standard Operating Procedure Number: 1-5 Recruitment of Participants for Clinical Trials Adopted: 02/2005 Revised: Page 5 of 6
  • 6. SCREENING and ENROLLMENT LOG Ethnicity A -African American AS -Asian C -Caucasian H -Hispanic O -Other