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PBSL clinical trial application checklist PBSL-F-78/02 PBSL CLINICAL TRIAL APPLICATION CHECKLIST Trials full title: Short title: Protocol no. Version no. Investigational product Sponsor: Contact person: Address: Telephone no. Fax no. Cell no. Email address: Date of application: 1
Checklist for submission of CTA Please tick (√) all documents submitted under applicant check list Applicant’s CTA Documents PBSL checklist checklist Cover Letter including list of documents submitted and their version number and date Completed clinical trial application form including cover page Application fee Clinical trial protocol with all the relevant sections including site-specific addendums. Informed consent information and form(s) Product information if the investigational medical product is registered: summary of product characteristics, patient information leaflet/package insert and labelling Investigator's brochure If applicable, synopsis of previous trials with the investigational medical product(s) If applicable, electronic copies of key peer reviewed publications following ICMJE recommendations to support the application Copy/ies of recruitment advertisement(s) (if applicable) and questionnaires Investigational medical product dossier1 (If applicable) Product information and certificate of analysis for the concomitant and rescue medications GMP certificate for the site(s) producing the IP(s) 2 Certificate(s) of analysis of the investigational medical product(s) Certificate(s) of accreditation for the central laboratories Signed declaration by the applicant Signed declaration by the local principal investigator Workload forms for investigators Signed curriculum vitae3 for all key staff participating in the conduct of the clinical trial, eg local principal investigator, international principal, co-investigators, study coordinator/manager, local and regional monitors, contract research affiliate etc Signed declaration(s) by each investigator(s)4 Signed joint financial declaration between the sponsor and the national principal investigator 2
Sponsor/PI Contractual Agreement Signed declaration by the sub-investigators and key staff participating in the clinical trial Signed declaration by the regional monitor(s) Proof of registration on PACTR or any PBSL approved Clinical Trial registry Active clinical trials insurance (Phase I, II, III) Proof of sponsor indemnification for investigators and other key study staff GCP certificates for the investigators Proof of registration of the key investigators with a professional statutory body (if applicable) Proof of professional indemnity (malpractice insurance) for key study staff (MD, Pharmacist, Nurse etc) Study budget contract Favourable opinion of the Sierra Leone Ethics and scientific review Committee Data Safety Monitoring Board charter and composition (where applicable) and CVs Labelled CD-ROM (List of files submitted on CD-ROM) 1 This is not required if the investigational medical product was granted registration by a mature national regulatory authority and will be used as defined therein, or if the investigational product is prequalified by the WHO 2 Investigational medical product comparator and placebo 3 Curriculum vitae to be submitted in the format provided in Annex 8 4 They could include the national principal investigator, or principal investigator and co-investigator as applicable. Each investigator is expected to sign and date one form. The form is provided in Annex Submitted by Received by Name Name Signature Signature Date Date 3
